BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDX BASE EUROPE W/12 IN REAR WHEELS

    MDR report key: 5940035 · Received September 9, 2016

    Report

    Report Number
    1525712-2016-02689
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 12, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE FDX-MCG "WENT REALLY FAST" AND THEN THE END USER HIT A CURB AND BROKE HIS HIP. THE FDX-MCG IS NOT DESIGNED TO TRAVERSE OVER OBSTACLES. THE FDX-MCG IS DESIGNED TO TRAVERSE FLAT TERRAIN AND RAMPS OR SLOPES NO GREATER THAN 9 DEGREES. THE END USER DID NOT HAVE HIS SEAT POSITIONING STRAP IN PLACE. THE USER MANUAL EXPLICITLY WARNS THAT NOT WEARING YOUR SEAT POSITIONING STRAP COULD RESULT IN DEATH OR SERIOUS INJURY. ALWAYS WEAR THE SEAT POSITIONING STRAP. THE SEAT POSITIONING STRAP HELPS REDUCE THE POSSIBILITY OF A FALL FROM THE WHEELCHAIR. THE DEALER ALSO ALLEGED THE CHAIR GOES INTO INTERMITTENT DRIVE LOCKOUT AND THE LEG RESTS WILL NOT MOVE UP MORE THAN 5 INCHES, IT IS UNCLEAR IF THIS HAPPENED BEFORE OR WAS CAUSED BY THE EVENT. THE DHR WAS REVIEWED, THE FDX-MCG MET SPECIFICATIONS PRIOR TO DISTRIBUTION. REGULAR MAINTENANCE RECORDS WERE NOT PROVIDED. RETURN OF THE FDX-MCG FOR INSPECTION IS NOT ANTICIPATED. MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT; THE DEALER AND THE END USER'S WIFE ARE UNABLE TO CLARIFY THE EVENT FURTHER. AT THIS TIME, THERE IS NOT ENOUGH INFORMATION TO DETERMINE IF THERE WAS A MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE DEALER STATES USER HIT CURB FELL FROM CHAIR. THE DEALER WAS NOT SURE IF THE PATIENT HAD HIS SEAT BELT ON. HE STATED THAT HE BROKE HIS HIP. THE DEALER DOES NOT HAVE ANY FURTHER INFORMATION. HE STATED HE DID NOT ASK ANY DETAILS. CHAIR GOES INTO INTERMITTENT DRIVE LOCKOUT AND ALSO STATES LEG WILL NOT MOVE UP MORE THAN 5 INCHES. THE DEALER DID NOT STATE THAT THE CAUSE OF HIM HITTING THE CURB WAS RELATED TO A DEFECT IN THE CHAIR ITSELF. UPDATE FROM CUSTOMER SERVICE ON (B)(6) 2016: THE END USER'S WIFE STATES HE WAS GOING IN BETWEEN TWO DRIVEWAYS AND IT WAS THE CURB BETWEEN THE TWO DRIVEWAYS THAT HE HIT AND SHE DESCRIBED IT AS "CATAPULTED" OUT OF THE CHAIR. SHE DOES NOT KNOW IF THE CHAIR HAD MALFUNCTIONED AT THE TIME OF THE INCIDENT. SHE STATES, GENERALLY, THAT THE CHAIR HAS ISSUED AND WILL GO INTO DRIVE LOCKOUT INTERMITTENTLY, BUT DOES NOT KNOW IF THAT WAS PRESENT AT THE TIME OF THE INCIDENT. SHE STATES THE LEGS DO NOT GO UP ALL THE WAY EITHER. SHE STATES IT WAS NOT HIS HIP THAT WAS INJURED, BUT THAT HE BROKE BOTH OF HIS FEMURS. THE END USER'S WIFE STATES THE END USER WAS NOT WEARING A SEAT STRAP AT THE TIME OF THE ALLEGED INCIDENT. SHE STATES THE CHAIR DOES NOT HAVE A SEAT STRAP, BUT HAS A CHEST STRAP, SIMILAR TO A VEST, THAT IS ONLY USED WHEN HE IS IN A VEHICLE. SHE STATES THIS WAS ALSO NOT IN USE AT THE TIME OF THE INCIDENT. SHE STATES "WHEN HE TURNED, IT WENT REALLY FAST AND IF HE HAD A SEAT BELT ON IT WOULD HAVE BEEN WORSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591944 FDX BASE EUROPE W/12 IN REAR WHEELS WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET FDX-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1