BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2018245 · Received March 9, 2011

    Report

    Report Number
    1525712-2011-00088
    Event Type
    Other
    Date Received
    March 9, 2011
    Report Date
    April 11, 2012
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER ALLEGES SMOKE WAS OBSERVED BY THEIR CUSTOMER. NO DETAILS OF THE ALLEGED EVENT HAVE BEEN PROVIDED. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. FILING SOLELY ON THE USER'S ALLEGATION THEY OBSERVED SMOKE. MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    INITIAL PR (B)(4) ISSUED MFG REPORT #1525712-2011-00088. COMPONENT, ACTUATOR MODEL #1120173, SERIAL #(B)(4) HAS BEEN RETURNED FOR AN EVALUATION. ENGINEERING STATED THAT THE MOTOR DID OVERHEAT AND THE DAMAGE WAS CONTAINED WITHIN THE METAL ENCLOSURE OF THE MOTOR HOUSING. ENGINEERING ALSO STATED THAT THE ACTUATOR HAD BEEN PLUGGED INTO A HIGH CURRENT FOR AN EXTENDED PERIOD OF TIME. INVACARE HAS DESIGN CONTROLS THAT LIMIT THE AMOUNT AND/OR DURATION OF CURRENT SUPPLIED TO THE ACTUATOR TO PREVENT OVERHEATING. CHAIRS ARE VALIDATED DURING MANUFACTURING SO THIS INCIDENT WAS DUE TO A USER ERROR. THE M71 IS NO LONGER MANUFACTURED. THE DEALER ALLEGES SMOKE WAS OBSERVED BY THEIR CUSTOMER. NO DETAILS OF THE ALLEGED EVENT HAVE BEEN PROVIDED. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. FILING SOLELY ON THE USER'S ALLEGATION THEY OBSERVED SMOKE. MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE DEALER'S CUSTOMER ALLEGES THE UNIT SMOKED. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE DEALER'S CUSTOMER ALLEGES THE UNIT SMOKED. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE M71SEAT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other