BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2665905 · Received July 24, 2012

    Report

    Report Number
    1531186-2012-00600
    Date Received
    July 24, 2012
    Report Date
    July 23, 2012
    Manufacturer
    GOODBABY
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH6074A, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1141494 REV B (SEP-07) 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 (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 IS UNKNOWN. THE DEALER CALLED STATING THAT THE RATCHET BAR IS TWISTING AND WON'T ALLOW THE PEGS TO ENGAGE ON THE SLOTS IN THE BAR, THE MALFUNCTION IS A METAL BAR THAT ADJUSTS THE POSITIONS. IT IS CONNECTED TO THE PIN THAT CONTROLS THE POSITIONING OF THE BACK. WITHOUT THIS LOCK/BAR AND PIN THE BACK CAN POTENTIALLY FALL COMPLETELY BACK. THE DEVICE HAS BEEN REMOVED FROM SERVICE UNTIL REPAIRED. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER STATES "THAT THE RATCHET BAR IS TWISTING AND WONT ALLOW BOTH PEGS TO ENGAGE ON THE SLOTS IN THE BAR." NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 INM GOODBABY IH6074A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 MO Other