BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2020133 · Received March 10, 2011

    Report

    Report Number
    1824206-2011-01421
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REPORTED THAT WHILE HE WAS PERFORMING AN ELECTRICAL SAFETY CHECK ON THE BED, THAT THE GROUND RESISTANCE WAS TOO HIGH. REPLACED THE POWER CORD TO RESOLVE THIS ISSUE. THE BED WAS LOCATED IN THE LABOR AND DELIVERY WARD.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATED THAT THE GROUND RESISTANCE WAS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM INC. P3700

    Patients

    Seq Age Sex Outcome Treatment
    1