Fisher & Paykel CPAP Masks "Recall For Correction&a

billbolton · Post by **billbolton** » Mon Dec 18, 2006 5:55 pm

I've recently received an Australian "recall for correction" notice from Air Liquide for my Fisher & Paykel HC405A mask. According to the notice the complete list of masks experiencing the problem is:

HC401A
HC401U
HC405A
HC406A
HC407A
HC407NIVB
HC431A
HC431B
HC431NIVB
HC451U
HC452A
HC452B
HC452NIVB
HC481A

The problem is with that "the plastic tabs incorporated into the connector components of these CPAP mask may break off if they are not cleaned in accordance with the Instructions for Use". If a tab breaks off in use "it may enter the CPAP system air path and there is a remote possibility that the broken tab may then enter the patient's upper airway".

The solution is to replace the connector piece with one of different design which does not have a tabbed locking rings, but instead has a continuous locking ring.

Masks manufactured since April 2006 have the new connector piece.

The recall in Australia has been made after consultation with the Therapeutic Goods Administration (the Australian regulator for this class of medical supply), and is being done voluntarily by Fisher & Paykel.

For Australian users of these masks, there is a number to call to obtain a replacement parts kit. The number is 1800 121 542 (this number is good for Australia only)

Fisher & Paykel apparently placed the recall for correction notice nationally in Australian newspapers on December 4th, 2006.

I presume that the same problem will exist with these masks in other countries, so you may want to ask your supplier what the replacement process is for your particular country.

Cheers,

Bill

Guest · Post by **Guest** » Wed Dec 20, 2006 10:57 am

I have a 431A. If by "connector" they mean the elbow piece, then mine does indeed have two "tabs" on each of the two ends of the elbow. These are long, one on each side of each connector, taking up about 1/4 the circumference of the circle, each.

Question: is the the old, or the new design? The wording of this recall makes it unclear, but I do see two tabs... very long ones, but they're tabs... the whole circle isn't a "continuous locking ring". But then again, maybe that's what they're calling it, because the old design had many more and much more obvious tabs.

I'm in the USA, and I have two 431's, one I got in July and one in October of this year. Both have the pair of "tabs" as described above, at both connection points on their elbows.

Does anyone know if I should be calling my DME or F&P about this? Are the Australian masks somehow different, and in the USA we're okay? And is this the "continuous locking ring" I have, or is the older, problematical design? It's hard to tell without close-up photos!

Thanks.

Should I be calling F&P about

DME Daddy · Post by **DME Daddy** » Wed Dec 20, 2006 11:06 am

The recall is a voluntary one affecting DME STOCK ONLY. There is no patient harm issue and no recall used masks. The recall is simply to improve the reliability of products reaching patients.

Doodeedoo · Post by **Doodeedoo** » Wed Dec 20, 2006 12:43 pm

I believe the recall should not be voluntary as it may be unsafe to use the mask with the old connector. According to a newspaper article in the New Zealand Herald most of the affected masks are in the Australian asian market. I am pasting the article dated December 4th:

______________________________________________________
Sleep apnoea mask recalled over safety fears

Fisher and Paykel Healthcare has recalled a piece of equipment used to treat people with sleep apnoea.

The problem concerns a tab on the plastic connector used in earlier models of a mask that keeps air flowing to patients.

The company said the tab on its Continuous Positive Airways Pressure system could break off if cleaning instructions were not followed correctly and there was a possibility a user could breath it in. Masks made since April are not affected by the recall.

Most of the masks are on the Australasian market and there have been only a small number of reported incidents with 0.01 per cent of the masks affected.

_______________________________________________________

I called my DME in Toronto and the person I talked to had no idea of any recall. He said he would check with F&P and call me back. So far no call. I will keep you posted.

Best regards and Merry Christmas (or other celebration you enjoy) to all,

David

luvmybipap · Post by **luvmybipap** » Wed Dec 20, 2006 12:52 pm

I received a full face mask in mid-2005. A piece did break off while in use and ended up in my mouth. At first I thought I lost a tooth overnight! This style mask is very unsafe and I would advise anyone to discontinue using it if they have not maintained it properly. I shudder to think of what could have happened and do not understand why there is no recall here in the states.

Guest · Post by **Guest** » Wed Dec 20, 2006 1:17 pm

What exactly is this maintenance issue? I've never detached the elbow from the mask, I just wash mask and elbow as a unit.

What is the proper maintenance method recommended by the manual, how does it prevent the issue, and how can/does improper maintenance provoke the issue?

Guest · Post by **Guest** » Wed Dec 20, 2006 1:18 pm

Anyone have close-up photos of the "bad" and "good" versions of the part? this would help GREATLY with people wanting to determine what kind they have....

Doodeedoo · Post by **Doodeedoo** » Wed Dec 20, 2006 2:13 pm

The DME called me back. His words were that the recall only affects distributors of the product, that is, connectors in stock, manufactured before their re-design, earlier this year, will be replaced. The replacement does not extend to consumers (sic).

There was no reasonable answer to my question that if consumers are the end users why is it that they are not affected.

David

Goofproof · Post by **Goofproof** » Wed Dec 20, 2006 2:45 pm

So just make sure the lawyer includes the DME in the lawsuit. Let's see Ingest part, operation to remove and repair damage to bowels, pain and suffering. Lawsuit= $1,000,000.00 + new mask. Cost to fix mask $1.00.

The CEO would rather you sue them, as the cost to the company can be deferred a few years, while litigation goes on, and they can hop out on their Golden Parachutes. I love big business. Jim

But it's still a better decision than Resmed made.

Guest · Post by **Guest** » Wed Dec 20, 2006 2:48 pm

I'm about to order a new HC431, from cpap.com. Anyone know if I can request that they make sure they're shipping me one with the new design for the connector piece?

I just wish I knew what the visual difference was... right now I have no clear way to know if a connector is the old or new design...

Bones · Post by **Bones** » Wed Dec 20, 2006 2:56 pm

I just pulled apart the elbow assembly on my 431A and there are no tabs anywhere. I got it from cpap.com at the end of September.

Guest...if you go to the spare parts page for the 431 on cpap.com and click on swivel elbow assembly there are several pictures. The first picture, with the assembly standing vertically is the one I have . If you go to the next picture the assembly is shown on it's side and this one has obvious tabs. I wouldn't worry about getting a bad one. F&P has been shipping the new assembly in the U.S. since spring. There were 2 ladies on another forum that had their 431 elbows coming apart, ie tabs breaking off. They contacted F&P and were given new masks with the corrected elbows. That was in late March if I recall.

Brian

_________________

CPAPopedia Keywords Contained In This Post (Click For Definition): cpap.com

Guest · Post by **Guest** » Wed Dec 20, 2006 3:51 pm

Bones wrote:Guest...if you go to the spare parts page for the 431 on cpap.com and click on swivel elbow assembly there are several pictures. The first picture, with the assembly standing vertically is the one I have . If you go to the next picture the assembly is shown on it's side and this one has obvious tabs.

Oh, EXCELLENT! Thanks a million! I have the "new" version. The reason I was unsure before seeing the pictures is that I didn't know what they meant by the word "tabs". Look closely at the "new" (standing upright) photo you mentioned and then look at where the thing connects to the mask (rightmost part of the image). Notice starting halfway down, and continuing nearly to the bottom, there is a long but only slightly protruding ridge... actually there are two, one on each side (the photo doesn't show the other one). I thought these might be the "tabs" F&P speaks of, and that perhaps this was the "old" design and that the "new" one didn't have these ridges.

I now see, based on the other (laying horizontal) image, what the actual "old" version of the part is like... and yes, the tabs are blatantly obvious, and are something totally different.

Bones wrote:I wouldn't worry about getting a bad one. F&P has been shipping the new assembly in the U.S. since spring. There were 2 ladies on another forum that had their 431 elbows coming apart, ie tabs breaking off. They contacted F&P and were given new masks with the corrected elbows. That was in late March if I recall.

Apparently you're right! Both my 431's (acquired in July and October this year) have the new part.

Thanks again, this was a huge help to me!

Bones · Post by **Bones** » Wed Dec 20, 2006 4:05 pm

Glad I could help. We've got enough to deal with without having to worry about choking on mask parts.

Brian

SamCurt · Post by **SamCurt** » Fri Feb 09, 2007 5:46 am

Sorry I have to bump this. UK has the same recall yesterday.

Machine	Mask

Additional Comments: Airmini, Medistrom Pilot 24, CMS 60C Pulse Oximeter, ResScan 6

Fisher & Paykel CPAP Masks "Recall For Correction&a

Fisher & Paykel CPAP Masks "Recall For Correction&a

Fisher & Paykel Mask Recall