BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2841025 · Received November 20, 2012

    Report

    Report Number
    1525712-2012-02252
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 17, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51, SERIAL NUMBER/DATE (B)(4)IS APPROXIMATELY 2 YEARS, 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1125085, REV.J(OCT-08), 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. A CALL WAS PLACED TO THE INITIAL REPORTER OF THIS INCIDENT. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE FOLLOWING INFORMATION WAS LEARNED THAT THE END USER ALWAYS HAD THE CHARGER ON. THE CHARGER END OF IT THAT YOU PUSH INTO THE CHAIR WAS FRAYED. HE STATED THAT CUSTOMER CONVEYED TO HIM THAT WHEN PLUGGING IN THE CHARGER, IT ARCED. ACCORDING TO THE REPORTER, THE ON BOARD CHARGER WORKS CORRECTLY, THE JOYSTICK LIGHTS UP FINE. IT WAS FOUND THAT DAMAGE HAD OCCURRED BUT ONLY TO OFF BOARD CHARGER. THE POWER CHAIR IS PRESENTLY WITH THE END USER. IF ANY FURTHER INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PER DEALER CONSUMER PLUGGED CHARGER INTO FRONT OF JOYSTICK AND STATED THERE WAS AN ARCH OR BLUE FLASH. DEALER IS NOT SURE HOW THEY WERE PLUGGING THE UNIT IN. THE FRONT CHARGING PORT IS PARTIALLY OUT BUT THE CHAIR IS FUNCTIONING FINE. NO REPORT OF AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51P

    Patients

    Seq Age Sex Outcome Treatment
    1 48 Other