BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1160530 · Received September 10, 2008

    Report

    Report Number
    1824206-2008-03375
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM ENGINEERING PERFORMED AN INVESTIGATION ON THE BED AT THE FACILITY, AND FOUND THE MATTRESS HOOK THAT ENGAGES THE LOCKING MECHANISM FOR THE FOOT SECTION (STOW & GO) WAS WORN. ENGINEERING FOUND THAT WHEN THE MATTRESS WAS MOVED FROM SIDE TO SIDE, THE FOOT SECTION LOCKING MECHANISM WOULD UNLOCK. THE FACILITY INFORMED HILL-ROM ENGINEERING THAT A NURSE WAS ALSO INJURED, WHEN WATER WAS SPILLED BY THE PT DURING THE FALL AND THE NURSE SLIPPED AND FELL. THE FACILITY WOULD NOT RELEASE INFO REGARDING THE INJURIES SUSTAINED BY THE PT OR NURSE AND WOULD NOT RELEASE THE PARTS TO HILL-ROM.

    Description of Event or Problem · 1

    ALLEGED THE PT WAS INJURED BY FALLING BETWEEN THE GAP OF THE SEAT AND FOOT SECTION OF THE BIRTHING BED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other