BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO T

    MDR report key: 7820451 · Received August 27, 2018

    Report

    Report Number
    3032618-2018-00005
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 27, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IMR
    PMA / PMN Number
    K990358
    Product Problem
    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. THE RETURNED SAMPLES OF THE ANTI-TIPS WERE TESTED, ALONG WITH SAMPLES FROM THE THEN-CURRENT LOT AND OF A DIFFERENT LOT. THE RESULTS OF A COMBINATION OF INTERNAL AND EXTERNAL/THIRD-PARTY TESTING INDICATES THAT THE MATERIAL OF THE ANTI-TIP TUBE USED ON THE CONSTRUCTION OF THIS CHAIR WAS SOFTER AND WEAKER THAN THE DESIGN SPECIFIED.

    Description of Event or Problem · 1

    THE PROVIDER CLAIMS THAT THEY WERE PERFORMING AN ANTI-TIP CHECK THAT THEY DO WITH EVERY CLIENT BY HAVING THE USER LEAN BACK ON THE ANTI-TIPS TO MAKE SURE THE FRONT CASTERS ARE NOT MORE THAN 4" OFF THE GROUND; THIS TEST IS PERFORMED ON A LEVEL SURFACE. WHILE THEY DID THIS CHECK, THE TECH NOTICED THE ANTI-TIP EXTENSIONS WERE BEGINNING TO BEND. THE TECH CLAIMS THAT BEFORE THIS TEST, HE ADJUSTED THE CENTER OF GRAVITY AS FAR BACK AS HE COULD, AND TRIED TO CHANGE THE POSITION WHERE THE ANTI-TIP WAS MOUNTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659302 AERO T WHEELCHAIR ANTI-TIP IMR TISPORT, LLC AERO T

    Patients

    Seq Age Sex Outcome Treatment
    1