BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES INFANT WARMER

    MDR report key: 4357276 · Received December 16, 2014

    Report

    Report Number
    4357276
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 13, 2014
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE BIOMED PREVENTIVE MAINTENANCE, IT WAS NOTED THAT THERE WERE TWO PANDA WARMERS WITH INTERMITTENT SYSTEM FAILURES. WHEN THE SYSTEM FAILURE OCCURS, THE MESSAGE "SYSTEM FAILURE 11 AA AA AA AA" IS DISPLAYED ON THE WARMER SCREEN AND AN AUDIBLE ALARM SOUNDS. THE WARMER STOPS WARMING BUT CONTINUES DISPLAYING THE FAILURE MESSAGE WITH THE AUDIBLE ALARM. THIS CONTINUES UNTIL THE WARMER POWER IS CYCLED OFF AND BACK ON. THE WARMER MAY OR MAY NOT OPERATE PROPERLY AFTER THE POWER HAS BEEN CYCLED. AFTER WORKING WITH THE MANUFACTURER TO TROUBLESHOOT THE DEVICE, ONE OF THE WARMERS HAS FAILED AGAIN AFTER A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825381 PANDA IRES INFANT WARMER WARMER, INFANT RADIANT FMT OHMEDA MEDICAL * *
    825382 PANDA IRES INFANT WARMER WARMER, INFANT RADIANT FMT OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *