BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2984627 · Received February 28, 2013

    Report

    Report Number
    1031452-2013-00424
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE BAR600IVC BARIATRIC BED PLASTIC GEAR BOX LOCATED AT THE BEDEND FLEXES OUTWARD CAUSING THE SHORT SLIVER DRIVESHAFT TO SKIP OUT OF POSITION. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87817 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other