BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY IV BED

    MDR report key: 2910700 · Received December 4, 2012

    Report

    Report Number
    1824206-2012-07887
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Removal / Correction Number
    Z-2082-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOD 471 HAS BEEN SCHEDULED FOR THIS BED. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE BED POPS OUT OF BRAKE MODE WHEN THE BED IS SHAKEN. NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1