BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4120569 · Received September 26, 2014

    Report

    Report Number
    3008262382-2014-01295
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 4, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    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

    WARRANTY REPLACING PER PRODUCT MANAGER FOR BATTERIES HAVE ENLARGED AND CRACKED AND SPILLED BATTERY ACID ALL OVER THE BOX AND HARNESSES. NO PROPERTY DAMAGE. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600745 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP AIRPTMBDY18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other