BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2132205 · Received June 6, 2011

    Report

    Report Number
    1525712-2011-00242
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 16, 2012
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER ALLEGES PARTS ARE FAILING ON THE CHAIR. CHAIR WAS APPROX 3 YEARS OLD AT THE TIME OF THE INCIDENT. MAINTENANCE HISTORY IS UNK. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME SO IT IS UNK IF A MALFUNCTION OCCURED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT INCLUDING ROUTINE MAINTENANCE. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT #1525712-2011-00242. POWER CHAIR MODEL # M94, SERIAL #(B)(4), JOYSTICK MODEL #1127291, SERIAL #(B)(4) AND CONTROLLER MODEL #1136697,SERIAL #(B)(4) HAVE BEEN RETURNED FOR AN EVALUATION. ENGINEERING STATED THAT THE STABILITY LOCK FUNCTIONED AS INTENDED. INSPECTION OF THE COMPONENTS SHOWED THAT THE TEETH WERE SLIGHTLY WORN AND THE BOLTS WERE LOOSE. THE LOCKNUT HOLDING THE WALKING BEAM TO THE BATTERY BOX WAS ALSO ALMOST ENTIRELY BACKED OFF OF THE THREADS. THE SHOULDER BOLT WAS STILL IN POSITION ALLOWING PROPER FUNCTIONING OF THE WALKING BEAM. THESE LOOSE ITEMS INDICATE A LACK OF MAINTENANCE. THE MAINTENANCE HISTORY IS UNKNOWN. THE STABILITY LOCK IS INTENDED TO KEEP THE WHEELCHAIR STABLE WHEN STOPPING ON INCLINES OF 9 DEGREES OR LESS. THE INCLINE THE CONSUMER WAS USING IS UNKNOWN. IT IS ALSO UNKNOWN WHETHER OR NOT THE CONSUMER WAS WEARING HIS SEAT POSITIONING STRAP. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT. NO SERIOUS INJURY ALLEGED. CONSUMER ALLEGES PARTS ARE FAILING ON THE CHAIR. CHAIR WAS APPROXIMATELY 3 YEARS OLD AT THE TIME OF THE INCIDENT. MAINTENANCE HISTORY IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. OPERATOR¿S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT INCLUDING ROUTINE MAINTENANCE. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES PARTS OF THE CHAIR ARE FAILING, CAUSING HIM TO BE THROWN FROM THE CHAIR. THE CONSUMER ALLEGES THERE WERE A TOTAL OF 5 ALLEGED INCIDENTS. THE CONSUMER DID NOT REPORT ANY OF THE OTHER ALLEGED INCIDENTS TO INVACARE. NO DETAILS HAVE BEEN PROVIDED REGARDING ANY SPECIFIC ALLEGED FAILURE. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES PARTS OF THE CHAIR ARE FAILING, CAUSING HIM TO BE THROWN FROM THE CHAIR. THE CONSUMER ALLEGES THERE WERE A TOTAL OF 5 ALLEGED INCIDENTS. THE CONSUMER DID NOT REPORT ANY OF THE OTHER ALLEGED INCIDENTS TO INVACARE. NO DETAILS HAVE BEEN PROVIDED REGARDING ANY SPECIFIC ALLEGED FAILURE. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE PRONTO M94

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other