BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TR, TRA, ZR, ZRA, AERO Z,

    MDR report key: 10884653 · Received November 20, 2020

    Report

    Report Number
    MW5098009
    Event Type
    Injury
    Date Received
    November 20, 2020
    Report Date
    November 18, 2020
    Manufacturer
    TILITE, TISPORT, PERMOBIL / PERMOBIL, INC.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    MOST MANUAL WHEELCHAIRS MANUFACTURED BY TILITE (PERMOBIL LLC) AT (B)(4) USA HAVE QUALITY PROBLEMS WITH ONE OF THE CRITICAL COMPONENTS: BACKREST HINGE. COMPANY REDESIGNED AND OUTSOURCED THIS CRITICAL COMPONENT TO (B)(4) SOMETIME IN LATE 2018 TO SAVE COST, RESULTING MULTIPLE CUSTOMER COMPLAINTS AND QUALITY ISSUES THEREAFTER. TILITE ISSUED CAPA IN MARCH 2019 TRYING TO ADDRESS IT, BUT THE CAPA IS STILL OPEN TILL TODAY. AT LEAST ONE LAWSUIT IS UNDER LITIGATION AND OVER 10% OF OUTPUT HAVE QUALITY PROBLEM AND/OR CUSTOMER COMPLAINTS. REWORK AND WARRANTY RATE IS HIGH TO THE ROOF SINCE. THE COMPANY SHOULD RECALL THIS COMPONENT IN 2019, GOING BACK TO OLD DESIGN THAT HAD NO QUALITY PROBLEM AT ALL. RATHER COMPANY DECIDED TO HIDE THE TRUTH AND AVOID RECALL THAT WILL COST COMPANY MILLIONS OF DOLLARS. SEVERAL EMPLOYEES WERE FIRED WHEN THEY SPOKE UP OR QUIT DUE TO THIS UNETHICAL PRACTICE. THE OLD DESIGN OF BACKREST HINGE WORKS FINE, NO QUALITY PROBLEM OR CUSTOMER COMPLAINTS WERE REPORTED. THE NEW DESIGN AND OUTSOURCED TO (B)(4) IS HAVING MAJOR QUALITY PROBLEMS AND AT LEAST ONE REPORTED DEATH. THE COMPANY IS NOT ALLOWING ITS QUALITY DEPARTMENT TO START A RECALL. ALL MANUAL WHEELCHAIRS MADE BY TILITE, TISPORT, PERMOBIL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345642 TR, TRA, ZR, ZRA, AERO Z, WHEELCHAIR, MECHANICAL IOR TILITE, TISPORT, PERMOBIL / PERMOBIL, INC.
    1345643 AERO X, 2GX WHEELCHAIR, MECHANICAL IOR TILITE, TISPORT, PERMOBIL / PERMOBIL, INC.
    1345644 PILOT WHEELCHAIR, MECHANICAL IOR TILITE, TISPORT, PERMOBIL / PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S