BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2437418 · Received February 3, 2012

    Report

    Report Number
    3004493922-2012-00035
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 13, 2012
    Report Date
    February 1, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRB, (B)(4) IS APPROXIMATELY 4 YEARS 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 DOUBLE AMPUTEE DUE TO A PREEXISTING MEDICAL CONDITION. THE CONSUMERS STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER IS A (B)(6) MALE WHOSE HEIGHT AND WEIGHT ARE UNKNOWN. CONSUMER STATED THAT HE WAS INDOORS IN HIS BED ROOM WHEN THE ALLEGED INCIDENT OCCURRED. HE REACHED DOWN (FORWARD) TO PICK SOMETHING UP WHEN THE SEAT POSITIONING STRAP ALLEGEDLY GAVE WAY CAUSING HIM TO FALL FORWARD ON HIS FACE. HE WENT TO THE EMERGENCY ROOM WHERE THEY DID X-RAYS AND DISCOVERED THAT HE ALLEGEDLY BROKE HIS NECK. THE CONSUMER STATED THAT HE IS CURRENTLY IN A BRACE. INVACARE CONTACTED THE DEALER AND ADVISE THEM THAT WE WOULD LIKE TO HAVE A TECHNICIAN GO OUT TO ASSESS THE UNIT AND REPLACE THE SEAT POSITIONING STRAP AS THE CONSUMER IS STILL USING THE DEVICE. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. PAGE 23 OF THE OWNER'S MANUAL STATES A WARNING, "DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN THE SEAT OR PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES". PAGE 40 OF THE OWNER'S MANUAL STATES A WARNING FOR THE SEAT POSITIONING STRAP, "THE SEAT POSITIONING STRAP IS A POSITIONING BELT ONLY. IT IS NOT DESIGNED FOR USE AS A SAFETY DEVISE WITHSTANDING HIGH STRESS LOADS", "IF SIGNS OF WEAR APPEAR, STRAP MUST BE REPLACED IMMEDIATELY". THE MAINTENANCE HISTORY OF THE DEVICE SHOWS THAT THE POWER CHAIR HAD A COMPLETE REFURBISHMENT DONE IN (B)(4) 2011. DEALER STATED THAT THE CONSUMER CALLED THE DEALERSHIP ON (B)(6) 2012 TO HAVE HIS BATTERIES REPLACED AND ADDITIONAL WORK DONE ON THE POWER CHAIR.

    Description of Event or Problem · 1

    USER WAS REACHING DOWN TO PICK SOMETHING UP WHEN THE SEAT POSITIONING STRAP ALLEGEDLY BROKE CAUSING THE USER TO FALL FROM THE CHAIR. EMERGENCY ROOM VISIT & X-RAYS ALLEGEDLY DETERMINED THAT USER BROKE HIS NECK.

    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 70 Other