BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZRA

    MDR report key: 7899903 · Received September 21, 2018

    Report

    Report Number
    3032618-2018-00009
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 21, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IMR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED IN THIS EVENT. THERE IS A RISK OF SERIOUS INJURY IN THE CASE OF A FAILURE OF THE ANTI-TIPS WHILE ENGAGED. IT IS UNCLEAR WHETHER THE USER WAS RECLINED ON THE ANTI-TIPS, OR PROPELLING WITH THE ANTI-TIPS BEING USED AS WHEELS INSTEAD OF THE FRONT CASTERS, WHICH ARE NOT RECOMMENDED BY THE OWNERS MANUAL, BUT THE OWNERS MANUAL DOES RECOMMEND IN CHAPTER 1 SECTION I: -2. NEVER USE YOUR CHAIR ON A SLOPE GREATER THAN 10% -9 ALWAYS LEAN OR PRESS YOUR BODY IN THE UPHILL DIRECTION. THIS WILL HELP SHIFT YOUR WEIGHT TO COUNTERACT THE CHANGE IN THE CENTER OF BALANCE CAUSED BY THE HILL, SLOPE OR RAMP. THE OWNERS MANUAL ALSO WARNS IN CHAPTER 1 WARNINGS SECTION A -2. IF YOUR ANTI-TIPS ARE SET TOO LOW, THEY MAY "CATCH" ON OBSTACLES THAT YOU CAN EXPECT TO ENCOUNTER IN NORMAL WHEELCHAIR USE. IF THIS HAPPENS, YOU MAY TIP OVER AND FALL. -4. ALWAYS KEEP YOUR ANTI-TIPS LOCKED IN PLACE IN THE "DOWN" POSITION UNLESS: --A. YOU HAVE AN ATTENDANT (BUT YOUR ATTENDANT MUST ROTATE THE ANTI-TIPS INTO THE "DOWN" POSITION WHENEVER HE OR SHE LEAVES YOU UNATTENDED IN YOUR CHAIR, EVEN FOR A MOMENT), OR --B. YOU HAVE TO CLIMB OR DESCEND A CURB OR STEP OR OVERCOME AN OBSTACLE. EVEN IF THIS IS THE CASE, ONLY UNLOCK THE ANTI-TIPS IF YOU CAN SAFELY CLIMB OR DESCEND THE CURB OR STEP OR OVERCOME THE OBSTACLE AND MAKE SURE THE ANTI-TIPS ARE LOCKED IN THE "UP" POSITION A REVIEW OF THE DHR INDICATES THAT THE WHEELCHAIR PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET ALL SPECIFICATIONS AS ORDERED BY THE DEALER WHEN IT LEFT THE FACILITY. THE ANTI-TIP IN QUESTION WAS REQUESTED TO BE RETURNED, BUT HAS NOT YET BEEN RETURNED. WE DO NOT HAVE ANY FURTHER INFORMATION ABOUT THE EVENT, OTHER THAN THESE ALLEGATIONS AT THIS TIME. IF MORE INFORMATION IS PROVIDED THAT CHANGES THE NATURE OF THE INVESTIGATION, A FOLLOW UP MEDWATCH FORM 3500A WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THAT THE ANTI-TIP EXTENSION ON A USER FRIENDLY ANTI-TIP BROKE DURING USE. THE END USER WAS REPORTEDLY NOT INJURED. ANTI-TIPS IN QUESTION WERE ORDERED SEPARATELY FROM THE CHAIR ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740367 ZRA WHEELCHAIR ANTI-TIP IMR TISPORT, LLC ZRA

    Patients

    Seq Age Sex Outcome Treatment
    1