BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2192372 · Received August 4, 2011

    Report

    Report Number
    9611451-2011-00474
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEFECT WAS FOUND DURING AN INSPECTION BY A HOSPITAL TECHNICIAN AND WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. RESULTS: THE TECHNICIAN HAD NOTED THAT THE UNIT'S POWER FAIL ALARM DID NOT FUNCTION DURING TESTING. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 021213. CONCLUSION: THE SUBJECT INFANT WARMER UNIT IS NEARLY NINE YEARS OLD; IT IS LIKELY THAT THE REPLACEABLE SUPER CAPACITOR ON THE PCB BOARD WORE OUT OVER TIME. THE SUPER CAPACITOR'S FUNCTION IS TO STORE SUFFICIENT ELECTRICAL CHARGE TO POWER THE WARMER'S VISUAL AND AUDIBLE ALARMS IN THE EVENT OF A FAILURE OF MAINS POWER. PART OF FISHER & PAYKEL HEALTHCARE'S QUALITY CONTROL PROCESS INVOLVES TESTING THE POWER FAILURE ALARM OF EVERY WARMER ON THE PRODUCTION LINE FOR FUNCTIONALITY PRIOR TO DISTRIBUTION. OUR REVIEW OF THE MANUFACTURING RECORDS FOR THIS COMPLAINT WARMER DID NOT REVEAL ANY DISCREPANCIES. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR. INCLUDED IN THE WARMER'S MAINTENANCE CHECKLIST IS A TEST OF THE SUPER CAPACITOR TO ENSURE IT IS OPERATING WITHIN SPECIFICATIONS. THE REPORTED MALFUNCTION WAS DISCOVERED DURING AN ANNUAL MAINTENANCE CHECK WITH NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN EVALUATED. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF ADDITIONAL INFORMATION AND/OR THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT DURING A SITE MAINTENANCE VISIT, A TECHNICIAN FOUND THAT THE POWER FAILURE ALARM WAS NOT WORKING AS REQUIRED ON AN IW930 COSYCOT INFANT WARMER. THE HEALTHCARE FACILITY ADVISED THAT THE REPORTED FAULT WAS OBSERVED DURING A MAINTENANCE CHECK WITH NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT DURING A SITE MAINTENANCE VISIT, A TECHNICIAN FOUND THAT THE POWER FAILURE ALARM WAS NOT WORKING AS REQUIRED ON AN (B)(4) COSYCOT INFANT WARMER. THE HEALTHCARE FACILITY ADVISED THAT THE REPORTED FAULT WAS OBSERVED DURING A MAINTENANCE CHECK WITH NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1