BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2746344 · Received September 15, 2012

    Report

    Report Number
    1525712-2012-01470
    Event Type
    Malfunction
    Date Received
    September 15, 2012
    Report Date
    September 15, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR #(B)(4) ISSUED MFR REPORT #1525712-2012-01470 INDICATING THE MANUFACTURER AS INVACARE (B)(4). THIS IS NOT AN INVACARE PRODUCT. THE MODEL AND MANUFACTURER ARE UNKNOWN. THE CORRECT MANUFACTURER HAS BEEN LOCATED AND THE COMPLAINT INFORMATION HAS BEEN FORWARDED TO THAT MANUFACTURER. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL UNKNOWN, SERIAL NUMBER/DATE CODE OF (B)(4) IS AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 1023891 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. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL UNKNOWN, SERIAL NUMBER/DATE (B)(4) IS AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 1023891, 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. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    END USER, (B)(6), ALLEGES THAT THE BRAKES NOT WORKING ALSO THAT THE HANDLE WHERE YOU TILT THE PATIENT IS NOT WORKING. NO REPORTED INJURY OR ILL EFFECT.

    Description of Event or Problem · 1

    END USER, (B)(6), ALLEGES THAT THE BRAKES NOT WORKING. ALSO THAT THE HANDLE WHERE YOU TILT THE PATIENT IS NOT WORKING. NO REPORTED INJURY OR ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other