BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3011880 · Received March 19, 2013

    Report

    Report Number
    3004493922-2013-00633
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(40. IT WAS REPORTED BY THE CONSUMER THAT THE M51PSEMIRED CUSTOM POWER WHEELCHAIR WOULD LOGOFF WITHOUT COMMAND, ALTHOUGH THE UNIT WAS FULLY CHARGED. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113679 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other