BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2170497 · Received July 21, 2011

    Report

    Report Number
    1525712-2011-00362
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    March 1, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - 03/02/2012 - FOLLOW-UP #001 - INITIAL PR #(B)(4) ISSUED UF/IMPORTER REPORT #1525712-2011-00362. POWER CHAIR, MODEL #3GTQ3-CG, SERIAL #(B)(4), JOYSTICK, MODEL #1127291, SERIAL #(B)(4) AND CONTROLLER, MODEL #1136898 REV E, SERIAL #(B)(4) WERE RETURNED FOR AN EVALUATION. THE CHAIR WAS APPROXIMATELY 2 YEARS OLD AT THE TIME OF THE INCIDENT. THE JOYSTICK RETURNED WITH THE CHAIR WAS NOT A CORRECT MODEL TO PERFORM SEATING FUNCTIONS. THE TILT FUNCTION WAS TESTED WITH A MK6 SPJ AND FUNCTIONED CORRECTLY. THE CHAIR WAS FUNCTIONALLY TESTED AND RESPONDED TO ALL COMMANDS GIVEN THROUGH THE JOYSTICK THAT WAS RETURNED. HOWEVER, THE POWER SWITCH DID NOT WORK CORRECTLY AND WOULD POWER DOWN THE ELECTRONICS AND THEN POWER UP AGAIN WITHOUT THE SWITCH BEING PRESSED A SECOND TIME. THE CONTROLLER AND JOYSTICK WERE THEN OPENED AND BOTH HAD EXTENSIVE LIQUID INGRESS. A SEALANT HAD BEEN PLACED OVER A TORN SPOT ON THE JOYSTICK BOOT. A FOREIGN SUBSTANCE INSIDE THE JOYSTICK (E.G. LIQUID OR OTHER CONDUCTIVE MATERIAL) COULD CAUSE UNPREDICTABLE COMMANDS FROM THE JOYSTICK. FLUIDS, ESPECIALLY URINE, ARE CONDUCTIVE AND CAN INITIATE A SHORT CIRCUIT MALFUNCTION. MANUFACTURER VIEWS THIS INCIDENT AS ABUSE AND/OR LACK OF MAINTENANCE. NO RMA HAS BEEN ISSUED AT THIS TIME. A PREVIOUS COMPLAINT WAS MAILED TO INVACARE IN (B)(6) 2011 REGARDING THE SAME CONSUMER AND THE ALLEGED INCIDENT. IT IS UNCLEAR IF THIS REPORT IS A DUPLICATE OF THE ONE RECEIVED IN (B)(6) 2011. THE PREVIOUS REPORT LISTED THE CONSUMER LIVING IN THE US. THIS COMPLAINT STATES THE CONSUMER RESIDES IN (B)(6). THE PREVIOUS ALLEGED INCIDENT WAS ENTERED ON PR # (B)(4). MDR FILED AS A PRECAUTION.

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW-UP #001. CAPA (B)(4) ISSUED MFG REPORT # 1525712-2011-00362 WITH ROCKFORD ORTHO APPL CO AS THE MANUFACTURER. THE CORRECT MANUFACTURER IS INVACARE (B)(4).

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED AT THIS TIME. A PREVIOUS COMPLAINT WAS MAILED TO INVACARE IN (B)(4) 2011 REGARDING THE SAME CONSUMER AND THE ALLEGED INCIDENT. IT IS UNCLEAR IF THIS REPORT IS A DUPLICATE OF THE ONE RECEIVED IN (B)(4). THE PREVIOUS REPORT LISTED THE CONSUMER LIVING IN THE US. THIS COMPLAINT STATES THE CONSUMER RESIDES IN (B)(4). THE PREVIOUS ALLEGED INCIDENT WAS ENTERED ON (B)(4). MDR FILED AS A PRECAUTION.

    Description of Event or Problem · 1

    THE CONSUMER'S DAUGHTER ALLEGES THE CHAIR BEGAN TO TILT ON ITS OWN WITH NO HUMAN CONTACT. THE CONSUMERS DAUGHTER ALLEGES THIS RESULTED IN A BROKEN LEG IN A PREVIOUS ALLEGED INCIDENT. THE SWITCH WAS FIXED SINCE THEN, BUT IT IS ALLEGEDLY HAPPENING AGAIN. NO INJURY APPEARS TO BE INVOLVED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CONSUMER'S DAUGHTER ALLEGES THE CHAIR BEGAN TO TILT ON ITS OWN WITH NO HUMAN CONTACT. THE CONSUMER'S DAUGHTER ALLEGES THIS RESULTED IN A BROKEN LEG IN A PREVIOUS ALLEGED INCIDENT. THE SWITCH WAS FIXED SINCE THEN, BUT IT IS ALLEGEDLY HAPPENING AGAIN. NO INJURY APPEARS TO BE INVOLVED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CONSUMERS DAUGHTER ALLEGES THE CHAIR BEGAN TO TILT ON ITS OWN WITH NO HUMAN CONTACT. THE CONSUMERS DAUGHTER ALLEGES THIS RESULTED IN A BROKEN LEG IN A PREVIOUS ALLEGED INCIDENT. THE SWITCH WAS FIXED SINCE THEN, BUT IT IS ALLEGEDLY HAPPENING AGAIN. NO INJURY APPEARS TO BE INVOLVED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention