BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3000754 · Received March 12, 2013

    Report

    Report Number
    1525712-2013-01931
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE REPORTABLE COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT EVENTS DATES WERE REPORTED, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4)).

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE TDXSP-CG CUSTOM POWER WHEELCHAIR TILT ACTUATOR WAS NOT FUNCTIONING PROPERLY, AND IT WAS REPLACED THREE TIMES. THIS IS THE THIRD UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103090 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other