BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY THREE BIRTHING BED

    MDR report key: 3062580 · Received March 16, 2013

    Report

    Report Number
    1824206-2013-01491
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    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

    THE TECHNICIAN REPLACED THE BRAKE CASTERS AND BRAKE DETENT MECHANISM TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THAT THE BRAKE CASTER WOULD SWIVEL WHEN PUSHED FROM SIDE WHILE IN BRAKE MODE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111593 AFFINITY THREE BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1