BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER AIR-SHIELDS INFANT WARMER

    MDR report key: 1590954 · Received January 28, 2010

    Report

    Report Number
    MW5014565
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    January 17, 2010
    Report Date
    January 22, 2010
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST DELIVERY, BABY BROUGHT TO NURSERY AND PLACED ON WARMER, WHICH WAS SET AT 37.4 C. TEMP PROBE PLACED ON BABY. BABY BATHED AND PROBE REPLACED AFTER BATH. THREE MINUTES LATER, WHEN BABY RE-CHECKED, THERE WAS A REDDENED AREA ON HER CHEST. ON FURTHER EXAM, IT WAS NOTED THAT THE WARMER HAD JUMPED TO 40.3C AND WAS NOT ALARMING. THE WARMER WAS IMMEDIATELY SHUT OFF AND REDNESS ON CHEST FADED AWAY WITHOUT ANY INTERVENTION. THE EVENT WAS WITNESSED BY A SECOND NURSE, THAT WARMER WAS SET ON "SKIN" AND NOT MANUAL, AND PROBE WAS ON BABY'S CHEST AND NOT ALARMING. WARMER WAS TAKEN OUT OF SERVICE AND MARKED "DO NOT USE" UNTIL SEEN BY BIOMED DEPARTMENT. THE MFR, DRAEGER MEDICAL, INC. WILL BE COMING TO (B) (6) HOSPITAL ON (B) (6) 2010 TO EVALUATE THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER AIR-SHIELDS INFANT WARMER INFANT WARMER FMT DRAEGER MEDICAL, INC. IICS-90

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA