BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 4047999 · Received August 7, 2014

    Report

    Report Number
    3032618-2014-00002
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 6, 2014
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER BELIEVES IT IS LIKELY THAT THE ALUMINUM CAMBER TUBE WAS DEFECTIVE.

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE PRESS PIN DROPPED OUT OF THE CAMBER TUBE ALLOWING THE ALUMINUM PLUG ON THE LEFT SIDE TO PULL FREE. IT HAPPENED AS HE WAS TRANSFERRING INTO HIS TRUNK: WHEEL, AXLE AND PLUG ALL FLEW OFF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466183 TILITE ZRA SERIES 2 WHEEL CHAIR, MECHANICAL IOR TISPORT, LLC ZRA SERIES 2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR