BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500 CORPUS

    MDR report key: 1588722 · Received December 31, 2009

    Report

    Report Number
    1221084-2009-00002
    Event Type
    Malfunction
    Date Received
    December 31, 2009
    Date of Event
    September 8, 2009
    Report Date
    December 31, 2009
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. MANUFACTURER EVALUATED THE WHEELCHAIR (B)(4) ON SEPTEMBER 14, 2009 AND INVESTIGATED THAT ALLEGED COMPLAINT THROUGH TESTING AT PERMOBIL AB IN (B)(4). THE INVESTIGATION DETERMINED THAT A COMMUNICATION ERROR WAS OCCURRING IN THE DRIVE ELECTRONICS OF THE WHEELCHAIR CAUSED BY A SOFTWARE BUG IN THE POWER MODULE, WHICH IS MANUFACTURED BY ANOTHER COMPANY. MANUFACTURER UPDATED THE SOFTWARE FOR THE POWER MODULE, WHICH HAS SOLVED THE ISSUE.

    Description of Event or Problem · 1

    WHEELCHAIR USER REPORTED THAT THE WHEELCHAIR STOPPED SUDDENLY AND HE FELL FROM THE WHEELCHAIR, SUFFERING FACIAL BRUISES. USER REPORTED FLASHING LIGHTS ON THE JOYSTICK. USER WAS NOT WEARING THE POSITIONING BELT ON THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL C500 CORPUS MOTORIZED WHEELCHAIR ITI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other