BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2575589 · Received May 16, 2012

    Report

    Report Number
    1525712-2012-00545
    Event Type
    Injury
    Date Received
    May 16, 2012
    Report Date
    May 14, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M61, (B)(4) IS APPROXIMATELY 2 YEARS 4 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. THE CONSUMER IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. 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 IS UNKNOWN. THE THERAPIST AT THE CONSUMERS FACILITY STATED THAT THE CONSUMER WAS RIDING IN A CAB WHEN THE DRIVER ALLEGEDLY SLAMMED ON THE BRAKES CAUSING THE CONSUMER TO GO FORWARD AND FRACTURE HIS LEFT LEG. THE THERAPIST HAD LIMITED INFORMATION. IT IS UNKNOWN IF THE CONSUMER WAS SITTING IN THE WHEELCHAIR WHILE RIDING IN THE CAB. PAGE 5 OF THE OWNERS MANUAL STATES, "WHEELCHAIR USERS SHOULD NOT BE TRANSPORTED IN VEHICLES OF ANY KIND WHILE IN WHEELCHAIRS. AS OF THIS DATE, THE DEPARTMENT OF TRANSPORTATION HAS NOT APPROVED ANY TIE-DOWN SYSTEMS FOR TRANSPORTATION OF A USER WHILE IN A WHEELCHAIR, IN A MOVING VEHICLE OF ANY TYPE. IT IS INVACARE'S POSITION THAT USERS OF WHEELCHAIRS SHOULD BE TRANSFERRED INTO APPROPRIATE SEATING IN VEHICLES FOR TRANSPORTATION AND USE BE MADE OF THE RESTRAINTS MADE AVAILABLE BY THE AUTO INDUSTRY. INVACARE CANNOT AND DOES NOT RECOMMEND ANY WHEELCHAIR TRANSPORTATION SYSTEMS." NO RMA HAS BEEN ISSUED AT THIS TIME FOR PRODUCT TO BE RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED CAB DRIVER SLAMMED ON BRAKES AND CUSTOMER WENT FORWARD. SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other