BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    634 AFFINITY

    MDR report key: 1964507 · Received December 22, 2010

    Report

    Report Number
    1824206-2010-11878
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT FOUND THE TRENDELENBURG LINKAGE IS BENT ON THE PATIENT RIGHT SIDE FROM THE TRENDELENBURG BOLT BACKED OUT. THE ACCOUNT REPLACED THE TRENDELENBURG BRACKET AND BOLT ON THE PATIENT RIGHT SIDE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BED IS NOT GOING INTO TRENDELENBURG. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 634 AFFINITY BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1