BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3133608 · Received May 29, 2013

    Report

    Report Number
    1525712-2013-04198
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE ((B)(4) 2012). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL ((B)(4) 2013). POTENTIAL FOR INJURY ASSOCIATED WITH THE RECEIVERS FOR BOTH SIDES OF THE CHAIR BEING CRACKED. THIS COULD CAUSE INSTABILITY OF THE PRODUCT.

    Description of Event or Problem · 1

    DEALER ADVISES THE RECIEVER FOR THE LEFT AND RIGHT SIDE OF THE CHAIR ARE CRACKED. SENT OUT TWO FOR WARRANTY REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237188 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other