BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO Z

    MDR report key: 7820455 · Received August 27, 2018

    Report

    Report Number
    3032618-2018-00006
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 14, 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
    CO, US
    Reporter Occupation
    OTHER

    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 THE THERAPIST TESTED THE ANTI-TIPS BEFORE GETTING THE PATIENT IN, AND AS A RESULT OF THE TEST THE ANTI-TIP TUBES BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658970 AERO Z WHEELCHAIR ANTI-TIP IMR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1