BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2771322 · Received October 4, 2012

    Report

    Report Number
    1525712-2012-01708
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS YET BEEN INITIATED FOR THIS ISSUE. MODEL PTORB, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1134839, WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. THIS DEVICE WAS BEING UTILIZED AS A DEMO CHAIR IN A (B)(6) FACILITY. THE PHYSICAL THERAPIST CALLED STATING THAT A FUSE HAD ALLEGEDLY MELTED. THE FACILITY WAS ADVISED NOT TO USE THE PRODUCT. ARRANGEMENTS ARE TO BE MADE TO HAVE THE PRODUCT RETURNED TO INVACARE FOR AN INSPECTION / EVALUATION. NO INJURY ALLEGED. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PHYSICAL THERAPIST FROM AN UNKNOWN FACILITY CALLED STATING THAT THERE IS ALLEGEDLY A MELTED FUSE ON THE PTORB, POWER TIGER PEDIATRIC POWER CHAIR. NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other