BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2868866 · Received December 11, 2012

    Report

    Report Number
    1525712-2012-02855
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    December 10, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSPBASE, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV. E (NOV-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 AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW-UP #001. INITIAL PR 44343 ISSUED MFG REPORT #1525712-2012-02855. THIS MDR WAS FILED IN ERROR. (B)(4) WAS RECEIVED ON (B)(4) 2012, THIS WAS THE CALL BACK THE DEALER SAID HE WOULD MAKE ON COMPLAINT #(B)(4) BUT WAS NOT LINKED TO THE ORIGINAL NUMBER. THE FIRST COMPLIANT RECEIVED DID NOT HAVE A SN THE 2ND DID. THUS 2 MDR'S WERE FILED FOR THIS COMPLIANT. A CALL WAS MADE TO THE DEALER ON (B)(4) 2013 THAT CONFIRMED THE TWO COMPLAINTS ARE ON THE SAME ISSUE FOR THE SAME CHAIR. THE PROVIDER STATES HE WAS CALLING BACK (ON COMPLAINT # (B)(4)) WHILE REPAIRING THE TDXSP CUSTOM POWER CHAIR. THE CHAIR WAS STILL OPERATIONAL, JUST GAVE A FAULT CODE. (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSPBASE, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV. E (NOV-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 AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE TDXSPBASE POWER WHEELCHAIR BRAKES WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATENT INJURY REPORTED.

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE TDXSPBASE POWER WHEELCHAIR BRAKES WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other