BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2930748 · Received January 28, 2013

    Report

    Report Number
    1525712-2013-00629
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 25, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGEDLY STATES AN UNSPECIFIED MANUAL WHEELCHAIR CROSSBRACE BROKE WHERE THE PIVOT LINK BOLTS ON THE CROSSBRACE. DEALER SAID IT DID NOT LOOK LIKE IT HAPPENED OVER A PERIOD OF TIME, WAS AN IMMEDIATE BREAK FROM TOO MUCH PRESSURE. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36938 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other