BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 2568672 · Received May 10, 2012

    Report

    Report Number
    1531186-2012-00236
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    June 7, 2012
    Manufacturer
    GOODBABY
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH6074A/IH61, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 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'S AGE, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR #(B)(4) ISSUED MFG. REPORT #1531186-2012-00236. THE ORIGINAL REPORT STATED THAT THE MANUFACTURER WAS INVACARE (B)(4) WHOSE REGISTRATION # IS (B)(4) WHILE THE MANUFACTURER AS INVACARE (B)(4), WHOSE REGISTRATION # IS (B)(4). THE CORRECT MANUFACTURER IS GOODBABY, REGISTRATION (B)(4). THIS IS A FOREIGN MANUFACTURER. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH6074A/IH61, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 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'S AGE, 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.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE PUSH BAR BROKE. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE PUSH BAR BROKE. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 INM GOODBABY IH6074/IH61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other