BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2990514 · Received March 5, 2013

    Report

    Report Number
    3004493922-2013-00516
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Removal / Correction Number
    N
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES MOTOR GIVING BRAKE FAULT. CHAIR STOPS OPERATING WHEN NOT LEVEL. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93090 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other