BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3083487 · Received April 29, 2013

    Report

    Report Number
    1525712-2013-03317
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4) (MDR AND 1 OF 2), AND (B)(4) (2 OF 2).

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TDXSP POWER WHEELCHAIR WAS INTERMITTENTLY DISPLAYING 4 FLASH ERROR CODE, AND DID NOT SWAP WHEN LEADS WERE CHANGED. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183920 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other