BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2781853 · Received October 11, 2012

    Report

    Report Number
    1525712-2012-01792
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    July 24, 2012
    Report Date
    October 10, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ARROW STORM, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 5 YEARS, 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151, REV.C(FEB-07), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE USER FACILITY HAS BEEN CONTACTED FOR ADDITIONAL DETAIL ON THIS INCIDENT, HOWEVER, THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. REPORTEDLY, THE END USER IS A HEAVY USER OF THE DEVICE. IT WAS ALSO REPORTED BY THE MECHANIC THAT HE REMOVED AND LOOKED AT THE BATTERIES AND NOTED BURNT MARKS ON THE BATTERY POST RED RUBBER SLEEVE. HE OBSERVED THE FUSE ON BATTERY HARNESS WAS LOOSE. IN HIS OPINION, IT SEEMED THAT THE LOOSE FUSE CAUSED ARCING WHICH CAUSED THE BURNING. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR (B)(4) ISSUED MFR REPORT #1525712-2012-01792 INDICATING THE MODEL # AS ARROW STORM. THE ACTUAL MODEL IS 3GSTAR-TS. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ARROW STORM, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 YEARS, 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151, REV.C(FEB-07) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE USER FACILITY HAS BEEN CONTACTED FOR ADDITIONAL DETAIL ON THIS INCIDENT, HOWEVER THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. REPORTEDLY, THE END USER IS A HEAVY USER OF THE DEVICE. IT WAS ALSO REPORTED BY THE MECHANIC THAT HE REMOVED AND LOOKED AT THE BATTERIES AND NOTED BURNT MARKS ON THE BATTERY POST RED RUBBER SLEEVE. HE OBSERVED THE FUSE ON BATTERY HARNESS WAS LOOSE. IN HIS OPINION, IT SEEMED THAT THE LOOSE FUSE CAUSED ARCING WHICH CAUSED THE BURNING. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING AN INCIDENT THAT OCCURRED IN (B)(6). IT WAS LEARNED THE DEVICE STOPPED WHILE USER WAS OUTSIDE DRIVING. A MECHANIC REPORTEDLY DIAGNOSED THE PROBLEM. THE JOYSTICK WAS ON BUT NO POWER. NO INJURY.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING AN INCIDENT THAT OCCURRED IN (B)(6). IT WAS LEARNED THE DEVICE STOPPED WHILE USER WAS OUTSIDE DRIVING. A MECHANIC REPORTEDLY DIAGNOSED THE PROBLEM. THE JOYSTICK WAS ON BUT NO POWER. NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Other