BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2120466 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00237
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. DURING A SERVICE CALL FOR THIS CHAIR, THE TECHNICIAN HAD REPLACED SEVERAL PARTS. THE TECHNICIAN WAS CHECKING HIS WORK WHEN THE CHAIR ALLEGEDLY TOOK OFF AT FULL SPEED, SPUN AROUND, AND HIT THE TECHNICIAN. INFORMATION INDICATES A SERVICE ERROR. THE DEALER HAS DISCARDED THE PARTS. A MORE THOROUGH ANALYSIS WOULD REQUIRE PRODUCT RETURN. MALFUNCTION HAS NOT BEEN ESTABLISHED. MDR FILED BASED ON AN ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE DEALER WAS INSTALLING NEW PARTS ON THE CHAIR. HE TURNED THE CHAIR ON AND IT ALLEGEDLY TOOK OF AT FULL SPEED, SPUN AROUND FOUR TIMES AND THE BACK CANE ALLEGEDLY HIT THE DEALER IN THE RIBS. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 3GAR-TS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR