FDA Adverse Event Malfunction Summary report: N

FULL FACE MASK

MDR report key: 1056620 · Received June 4, 2008

Report

Report Number: 9611451-2008-00135
Event Type: Malfunction
Date Received: June 4, 2008
Date of Event: February 6, 2008
Report Date: February 6, 2008
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Product Code: MNT
PMA / PMN Number: K060044
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADD'L LOT NUMBERS ARE 07116 AND 070904. ADD'L MFG DATES ARE 11/6/2007 AND 9/4/2007. THE INVESTIGATION WAS CONDUCTED BASED ON THE RETURNED MASKS, EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE SEALS WERE HELD TO THE MASK BASES BY FRICTION. THE FRICTION APPLIED WAS NOT SUFFICIENT ENOUGH TO HOLD THE SEALS TO THE BASES OF THE MASKS. LOT NUMBER 071108: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 071106: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT. LOT NUMBER 070904:OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: WE HAVE AN OPEN CAPA PROJECT TO ADDRESS THIS ISSUE AND TO IMPLEMENT POTENTIAL DESIGN SOLUTIONS WE HAVE DEVELOPED TO PREVENT SEPARATION ISSUES OCCURRING IN THE FUTURE. WE ARE CURRENTLY IMPLEMENTING AN ADDED SILICONE ADHESIVE STEP (THE APPLICATION OF AN ADHESIVE BETWEEN THE SILICONE FACIAL SEAL AND THE PLASTIC MASK BASE) IN OUR PRODUCTION PROCESS.

Description of Event or Problem · 1

A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT THE SEALS OF THREE RT040S FULL FACE MASKS WERE DETACHED FROM THE MASK BASES PRIOR TO THE OPENING OF THE PACKAGE. NO PT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FULL FACE MASK		MNT	FISHER & PAYKEL HEALTHCARE, LTD.	RT040S	071108

Patients

Seq	Age	Sex	Outcome	Treatment
1