BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO Z

    MDR report key: 7899898 · Received September 21, 2018

    Report

    Report Number
    3032618-2018-00008
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 23, 2018
    Report Date
    September 21, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 X-SHORT ANTI-TIPS SHIPPED WITH THIS CHAIR ARE PART OF A KNOWN POPULATION OF X-SHORT ANTI-TIPS THAT WERE POTENTIALLY NOT MADE TO THE DESIGN SPECIFICATIONS. TISPORT, LLC HAS INITIATED A VOLUNTARY MARKET CORRECTION TO MITIGATE THE RISK OF INJURY TO THE END USER, WHICH IS PENDING FDA APPROVAL AND ASSIGNMENT OF CORRECTION/REMOVAL REPORTING NUMBER UNDER 21 USC 360I(F). THIS VOLUNTARY MARKET CORRECTION IS TRACKED UNDER CPA NO. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THE ANTI-TIP EXTENSION TUBE BENT. THE DHR INDICATES THE EXTENSION TUBE WAS AN X-SHORT STANDARD ANTI-TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740698 AERO Z WHEELCHAIR IOR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1