FDA Adverse Event Malfunction Summary report: N

COSYCOT INFANT WARMER

MDR report key: 1038403 · Received May 5, 2008

Report

Report Number: 9611451-2008-00249
Event Type: Malfunction
Date Received: May 5, 2008
Report Date: August 24, 2007
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Product Code: FMT
PMA / PMN Number: K971695
Removal / Correction Number: Z-0485-2007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADD'L LOT NUMBERS: 050530, 060905. ADD'L MFG DATES: 05/30/2005, 09/05/2006. REPLACE THE ELEVATOR BASES OF THE INFANT WARMERS. METHOD: TWO OUT OF 12 LEANING BASES WERE RETURNED FOR INVESTIGATION. RESULTS: ONE OF THE RETURNED BASES WAS FOUND TO BE LEANING TO THE LEFT. THE OTHER ONE, WHICH WAS ALSO LEANING, HAD CRACKED RIBS AT THE REAR LEFT LEG. LEANING BASES AND CRACKING LEGS OF THE COSYCOT INFANT WARMER, DUE TO EXCESSIVE WEIGHT LOADING, ARE KNOWN PROBLEMS. TOTAL WEIGHT OF THE DEVICE, INCLUDING ACCESSORIES AND PT, EXCEEDING 115 KG MAY, UNDER CERTAIN CIRCUMSTANCES, CAUSE CRACKS IN THE PLASTIC LEGS' BASE AND DAMAGE TO THE BASE ELECTRIC ELEVATOR MECHANISM. CONCLUSION: WE HAVE AN OPEN CAPA TO ADDRESS THESE ISSUES. THE CORRECTIVE ACTION, INFORMING THE USERS OF THE MAXIMUM WEIGHT FOR THE COSYCOT INFANT WARMER AND TO INSPECT THE BASES OF THEIR COSYCOTS, IS EXPECTED TO BE COMPLETED BY END OF MAY 2008. THIS CORRECTIVE ACTION HAS BEEN NOTIFIED TO THE (B)(4) DISTRICT OFFICE UNDER THE REPORTING NUMBER Z-0485-2007.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6), REPORTED THAT TWELVE IW930 COSYCOT INFANT WARMERS WERE LEANING TO THE LEFT, 10 OF WHICH HAD UPS (UNINTERRUPTIBLE POWER SUPPLY) ON THE BASES. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COSYCOT INFANT WARMER		FMT	FISHER & PAYKEL HEALTHCARE, LTD.	IW930	050513

Patients

Seq	Age	Sex	Outcome	Treatment
1