BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFINITY BED

    MDR report key: 1647719 · Received March 26, 2010

    Report

    Report Number
    1824206-2010-04773
    Event Type
    Other
    Date Received
    March 26, 2010
    Date of Event
    December 1, 2009
    Report Date
    March 4, 2010
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN SPOKE WITH THE ACCOUNTS MAINTENANCE. THEY INDICATED THAT FOUR DIFFERENT PEOPLE IN MAINTENANCE LOOKED AT THE FOOT SECTION, AND FOUND THAT IF THE FOOT SECTION WAS LATCHED PROPERLY, IT WOULD HOLD PROPERLY. NO PROBLEM WAS FOUND WITH THE BED. THE HILL-ROM TECHNICIAN WAS NOT GIVEN ACCESS TO INSPECT THE BED BECAUSE MAINTENANCE HAD PLACED IT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE PT'S HUSBAND WAS SITTING ON THE BOTTOM HALF OF A LABOR BED AND THE BED BROKE OUT FROM UNDER HIM AND HE FELL ONTO THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM RITTER 3600

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR