BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BIRTHING BED

    MDR report key: 3100176 · Received April 29, 2013

    Report

    Report Number
    1824206-2013-02401
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE E RING CAME OFF THE D PIN THAT SECURES THE SIDE RAIL AND THIS CAUSED THE D-PIN TO FALL OUT OF THE SIDE RAIL. THE ACCOUNT REPLACED THE E RING AND D PIN ON THE SIDE RAIL TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE SIDE RAIL WOULD NOT LATCH. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184203 AFFINITY 4 BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1