BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2671918 · Received July 26, 2012

    Report

    Report Number
    3004493922-2012-00246
    Event Type
    Injury
    Date Received
    July 26, 2012
    Report Date
    July 26, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRB, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143206 REV G (FEB-09) 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 CONSUMER IS A FEMALE, (B)(6). THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE AS STATED BY THE DEALER: IN THE LAST SIX MONTHS HE HAS REPLACED THE BATTERIES, BATTERY HARNESS, AND OTHER SIGNIFICANT ADJUSTMENTS TO THE CHAIR PER THE CONSUMER'S REQUEST. . THE DEALER CALLED STATING THAT THE M41SRB POWER CHAIR ALLEGEDLY SURGES FORWARD WHEN THE CHAIR IS TURNED OFF. THE CONSUMER REPORTED THAT THE CHAIR HAD SURGED FORWARD AND SHE HAD ALLEGEDLY BROKEN TWO TOES. THE DEALER DID NOT SEE HER IN A BOOT OR THAT HER TOES WERE SWOLLEN. HE STATED HE DOES NOT BELIEVE THAT SHE BROKE HER TOES, JUST BRUISED THEM. WHEN THE CONSUMER CONTACTED THE DEALER ABOUT THE INCIDENT, THE DEALER WAS UNABLE TO DUPLICATE THE ISSUE. HE TESTED THE UNIT 10 TIMES (TURNING UNIT OFF AND ENGAGING JOYSTICK). HE TOOK A NEW JOYSTICK AND PLACED IT ON THE CHAIR AND TESTED IT AGAIN AND NOTHING HAPPENED. HE CHECKED THE UNIT AFTER IT WAS TURNED OFF AND THE VOLT METER DISPLAYED NO CHARGE. THE DEALER DOES NOT FEEL THAT THE CHAIR IS MALFUNCTIONING IN ANY WAY. THE CHAIR HAS ALWAYS WORKED WHENEVER HE WENT OUT TO LOOK AT THE POWER CHAIR. DEALER OBSERVED THAT THE TWO INCIDENTS ALLEGED OCCURRED IN THE EVENING. THE CONSUMER TAKES MEDICATION FOR SLEEP. THE DEALER FEELS THAT IT HAPPENS AFTER THE CONSUMER IS MEDICATED. THE DEALER ALSO STATED THAT THE CONSUMER'S DOCTOR DOES NOT WANT HER DRIVING THE CHAIR ALL THE TIME. HE WANTS HER TO BE MORE MOBILE. THE DEALERSHIP PROVIDED THE CONSUMER WITH A FREE MANUAL CHAIR TO ACCOMMODATE HER TRAVEL OUTSIDE THE HOME AS WELL. CONSUMER HAS HAD THIS CHAIR FOR APPROXIMATELY 9 MONTHS AND THE DEALER CONFIRMED THAT THE CONSUMER IS WELL VERSED IN USING THE CHAIR AND DOES NOT HAVE DIFFICULTY DRIVING IT. A REPLACEMENT JOYSTICK WAS RECEIVED BY THE DEALER AND HE WILL BE GOING OUT TO DO THE REPLACEMENT. THE ORIGINAL JOYSTICK WILL BE RETURNED TO INVACARE FOR AND INSPECTION / EVALUATION.

    Description of Event or Problem · 1

    DEALER CALLED STATING THAT THE POWER CHAIR ALLEGEDLY SURGES FORWARD WHEN IT IS TURNED OFF. MINOR INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other