BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROLLED WALL MOUNT INFANT WARMER

    MDR report key: 1759379 · Received June 23, 2010

    Report

    Report Number
    9611451-2010-00393
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Report Date
    May 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE WALL MOUNT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). THE WARMER WAS VISUALLY INSPECTED AND TESTED FOR FUNCTIONALITY. THE HARNESS AND HEATING ELEMENT COMPONENTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE ((B)(4)) FOR FURTHER INSPECTION AND RESISTANCE TESTED USING A MULTIMETER. RESULTS: THERE WAS NO DAMAGE TO THE EXTERNAL CONTROLLER ASSEMBLY OR WARMER HEAD. UPON FURTHER INSPECTIONS AND OPENING OF THE UNIT IT WAS DISCOVERED THAT TWO OF THE INTERNAL ELECTRICAL CONNECTORS WERE DAMAGED. WHEN THE WARMER WAS POWERED ON, IT DISPLAYED AN ERROR CODE TO ALERT THE USER TO THE FAULT CONDITION AND NO HEAT WAS GENERATED. THE RESISTANCE OF THE HEATING ELEMENT WAS FOUND TO BE NORMAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070615. CONCLUSION: THE HEATER COMPONENTS WERE FOUND TO BE DAMAGED. 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. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW980 WALL MOUNT INFANT WARMER "HEATS INTERMITTENTLY". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROLLED WALL MOUNT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD IW980JEU 070615

    Patients

    Seq Age Sex Outcome Treatment
    1