BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2853685 · Received December 3, 2012

    Report

    Report Number
    1525712-2012-02499
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 29, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSI-HD-S, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143190, REV.K(MAR-11) 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 MALFUNCTION HAS NOT BEEN CONFIRMED. PLEASE NOTE THE ADDITIONAL INFORMATION GATHERED ON THIS INCIDENT: I RECEIVED A RESPONSE FROM THE DEALER. SHE STATED THAT FOLLOWING: THE POWER CHAIR IS BRAND NEW, SPENT APPROXIMATELY AN HOUR INSTRUCTING THE PATIENT ON USE OF THE POWER WHEELCHAIR AT THE TIME OF DELIVERY AND THE INJURY WAS NOT REPORTED TO A DOCTOR. THE CONSUMER SUSTAINED A SCRATCH ON THE BACK OF THE CALF. THE CONSUMER IS TRANSFERRED INTO THE WHEELCHAIR BY MEANS OF A PATIENT LIFT, SO SHE IS SET DOWN INTO THE WHEELCHAIR FROM ABOVE. IN SPEAKING WITH THE DEALER SHE FEELS THAT A SOLUTION WOULD BE TO GET SOME SORT OF PADDING TO GO ONTO THE LEG REST TO MAKE THE PLASTIC LESS ROUGH. LAMB'S WOOL CALF PAD COVERS WILL BE APPLIED. ANY FURTHER INFORMATION WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    AN END USER HAS REPORTED SHE HAS SCRAPED LEG ON LEGREST AND DREW BLOOD. A CALL WAS PLACED TO THE DEALER WHO PROVIDED THE UNIT TO THE END USER. PLEASE SEE ADDITIONAL INFORMATION INCLUDED IN THIS REPORT THAT WAS RECEIVED ON THIS INCIDENT. NO MEDICAL INTERVENTION OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other