BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1806289 · Received August 5, 2010

    Report

    Report Number
    9611451-2010-00481
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Report Date
    July 8, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT UPPER HARNESS AND HEATING ELEMENT WERE RECEIVED FOR INVESTIGATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE AND WERE RESISTANCE TESTED USING A MULTIMETER. RESULTS: ONE TERMINAL, WHICH CONNECTS A WIRE TO THE HEATING ELEMENT, WAS FOUND TO BE DISCOLORED AND APPEARED BURNT. THE TAB WHERE THE CONNECTOR IS INSERTED SHOWED SOME SIGNS OF DAMAGE AND CORROSION. A SECTION OF THE INSULATION ON THE WIRE WAS MELTED. THERE WAS NO DAMAGE TO THE OTHER END OF THE HEATING ELEMENT TERMINAL, WHICH STILL CREATES A GOOD CONNECTION. THE RESISTANCE OF THE HEATING ELEMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 051121. CONCLUSION: IT IS POSSIBLE THAT CORROSION OR A LOOSE TERMINAL IN THE HEATER ELEMENT CAUSED INCREASED RESISTANCE, RESULTING IN A FAULTY CONNECTION AND INCREASED HEAT GENERATION IN THE WARMER HEAD. THE WARMER DISPLAYED AN ERROR CODE AND ENTERED A FAIL-SAFE STATE WHERE THE HEATER ELEMENT IS DISABLED AND THE INFANT WARMER ALARMS TO ALLOW THE USER TO ACT AND PROVIDE AN ALTERNATE MEANS OF WARMING. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A WIRE IN THE HARNESS ASSEMBLY OF AN IW910 MOBILE INFANT WARMER WAS "BURNED OUT" CAUSING AN OPEN CONNECTION. IT WAS ALSO REPORTED THAT THE INFANT WARMER GENERATED AN E17 ERROR CODE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD. IW910JEU 051121

    Patients

    Seq Age Sex Outcome Treatment
    1