BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2884415 · Received December 22, 2012

    Report

    Report Number
    1525712-2012-03211
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 20, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) - NO MDR HAS BEEN INITIATED FOR THIS ISSUE. THE CONSUMER IS A FEMALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    CONSUMER STATED THAT THERE IS A SAFETY ISSUE WITH THE CONTROLLER ON A FDX POWER CHAIR. USER ALLEGES INJURY-SPECIFICS UNKNOWN. MALFUNCTION NKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other