BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BED

    MDR report key: 2860704 · Received October 29, 2012

    Report

    Report Number
    1824206-2012-06928
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT ADJUSTED THE TRENDELENBERG LIMIT SWITCH TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED IS LOWERING ON ITS OWN. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 4 BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1