BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2031708 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00123
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    March 18, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY IS REPORTED. DEALER WAS OPERATING THE TILT ON THE CHAIR AND HEARD A NOISE WHILE THE ACTUATOR WAS ACTIVATED, AND ALLEGES THE SEATING SYSTEM WAS CONTINUING UP. THE DEALER STOPPED THE CHAIR. PROGRAM PARAMETERS OF THE CHAIR ARE UNK AT THIS TIME. MDR FILED BASED ON ALLEGED UNINTENDED MOVEMENT. MDR FILED BASED ON ALLEGED UNINTENDED MOVEMENT. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CHAIR WAS TILTED AND THEN RECLINED WHEN THE TECHNICIAN AND CONSUMER ALLEGEDLY HEARD A NOISE AND WENT TO THE BACK OF THE CHAIR. THE TECHNICIAN ALLEGES THE ACTUATOR WAS PULLING THE ENTIRE SEATING SYSTEM STRAIGHT UP IN THE AIR. THE TECHNICIAN WAS ABLE TO STOP ALL FUNCTIONS ON THE CHAIR. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1