BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL CONTROLLED INFANT WARMER

    MDR report key: 2893785 · Received January 2, 2013

    Report

    Report Number
    9611451-2013-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 4, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: A PREVENTATIVE MAINTENANCE CHECK WAS PERFORMED ON THE IW990 INFANT WARMER BY A TRAINED FISHER & PAYKEL HEALTHCARE (FPH) SERVICE PERSONNEL IN OUR (B)(4) REGIONAL OFFICE. THE UNITS WERE ELECTRICAL SAFETY TESTED AND PERFORMANCE CHECKED AS PART OF THE PREVENTATIVE MAINTENANCE CHECK. RESULTS: THE PREVENTATIVE MAINTENANCE CHECK REVEALED THAT THE POWER FAIL ALARM OF THE INFANT WARMER DID NOT FUNCTION. CONCLUSION: THE "POWER FAIL" ALARM IS AN INDICATOR OF MAIN POWER SUPPLY FAILURE. THE ENERGY STORED IN THE CAPACITOR OF THE POWER PCB BOARD USUALLY PROVIDE UP TO 10 MINUTES OF PULSING ALARM IN THE EVENT THAT THE POWER FAILS WHILE THE UNIT IS SWITCHED ON. THE RED INDICATOR LIGHT OF THE "POWER FAIL" ALARM ON THE FRONT CONTROL PANEL WILL THEN FLASH AND PRODUCE AN AUDIBLE ALARM WHEN THE POWER SUPPLY TO THE INFANT WARMER HAS FAILED. BASED ON THE SERVICE REPORT PROVIDED, A CAPACITOR FROM THE POWER PCB (PRINTED CIRCUIT BOARD) WAS FOUND TO BE DEFECTIVE, CAUSING THE "POWER FAIL" ALARM NOT FUNCTION. 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. THE DEVICE SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS SHOULD PERFORM SAFETY , PERFORMANCE AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR. THE FAULT ON THE RETURNED INFANT WARMERS WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE CHECK WITH NO PATIENT INVOLVEMENT. THE IW990 UNIT WAS REPAIRED AND PERFORMANCE TESTED PRIOR TO BEING RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REQUESTED A ROUTINE SERVICE FOR AN IW990 MANUAL CONTROLLED INFANT WARMER. DURING A ROUTINE SERVICE CONDUCTED BY FISHER & PAYKEL HEALTHCARE REGIONAL OFFICE IN (B)(4), IT WAS NOTED THAT THE POWER FAIL ALARM DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904 MANUAL CONTROLLED INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW990

    Patients

    Seq Age Sex Outcome Treatment
    1