BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2639475 · Received July 5, 2012

    Report

    Report Number
    1525712-2012-00856
    Event Type
    Malfunction
    Date Received
    July 5, 2012
    Date of Event
    August 1, 2010
    Report Date
    July 3, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR. NO RMA HAD BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQSP, SERIAL NUMBER/DATE CODE (B)(4) WAS APPROXIMATELY 2 MONTHS OLD AT THE TIME OF THE INCIDENT. THE OWNER'S MANUAL PART NUMBER 1143151 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL COULD ALSO BE FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAD FULLY READ AND UNDERSTOOD THE OWNER'S MANUAL. DOCUMENTATION PROVIDED WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DID NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD HAVE CONTACT INVACARE. THE CONSUMER IS A (B)(6) MALE WHOSE HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER WAS DRIVING UP THE SIDEWALK AND WENT OVER A BUMP OR 6 INCH ELEVATION. THE CONSUMER TRIED TO GO OVER THE ELEVATION. THE BACK WHEEL ALLEGEDLY WAS NOT FLUSH AGAINST THE GROUND AND HE ALLEGEDLY FELL BACKWARDS. THE CONSUMER WAS WEARING A POSITIONING STRAP. ACCORDING TO THE CONSUMER, BOTH WHEELS WERE OFF THE GROUND AND THE CONSUMER ALLEGEDLY FELL FULLY ON HIS BACK. THE CONSUMER DOES NOT USE FRONT RIGGINGS. HE FRONT LOADS THE CHAIR. THE DEALER HAS COMMUNICATED TO THE CONSUMER THAT HE NEEDS TO SIT PROPERLY IN THE CHAIR TO AVOID TIPPING. THE CHAIR IS CURRENTLY OPERATIONAL. THE DEALER HAS ADJUSTED THE BACK ANGLE TO 90 DEGREES. REAR ANTI-TIPPERS WERE RECOMMENDED AND SENT HIM A PAIR AT NO CHARGE. PG 29 MANUAL 1143151 - WARNING: COPING WITH EVERYDAY OBSTACLES. COPING WITH THE IRRITATION OF EVERYDAY OBSTACLES CAN BE SOMEWHAT ALLEVIATED BY LEARNING HOW TO MANAGE YOUR WHEELCHAIR. KEEP IN MIND YOUR CENTER OF GRAVITY TO MAINTAIN STABILITY AND BALANCE. WHILE THE WHEELCHAIR IS DESIGNED FOR USE PRIMARILY IN AND AROUND THE HOME, THE PROVIDER SHOULD DETERMINE WHETHER THIS WHEELCHAIR IS SUITABLE FOR THE ACTUAL ENVIRONMENT IN WHICH THE WHEELCHAIR WILL BE USED. DO NOT ATTEMPT TO DRIVE OVER CURBS OR OBSTACLES. DOING SO MAY CAUSE YOUR WHEELCHAIR TO TURN OVER AND CAUSE BODILY HARM OR DAMAGE TO THE WHEELCHAIR.

    Description of Event or Problem · 1

    THE CONSUMER WENT OVER A CRACK IN THE SIDEWALK WHEN THE CHAIR ALLEGEDLY WENT UP AND FLIPPED BACKWARDS, CAUSING THE CONSUMER TO HIT THEIR HEAD. NO SERIOUS INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 Other