BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE

    MDR report key: 11083953 · Received December 28, 2020

    Report

    Report Number
    3032618-2020-00007
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 28, 2020
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDWATCH REPORT (MW5098009) WE REVIEWED THE ALLEGED COMPLAINT AND DETERMINED IT IS NOT RELATED TO A SPECIFIC INCIDENT OR SPECIFIC PRODUCT-RELATED MALFUNCTION. THE REPORT ALLEGES SYSTEMIC QUALITY ISSUES OF A TISPORT COMPONENT (THE PRECISION LOCK BACKREST HINGE) COMPOUNDED WITH SUBSEQUENT INACTION BY TISPORT. WE OPENED A COMPLAINT TO ADDRESS THE ALLEGATIONS MADE IN THE REPORT AND ARE SUBMITTING AN MDR IN LINE WITH OUR COMPLAINT HANDLING PROCEDURE. THE REPORT ALLEGES TISPORT PURPOSELY ATTEMPTED TO HIDE AN ISSUE RELATED TO THE BACKREST HINGES, INCLUDING A COMPLAINT THAT IT REPORTEDLY LED TO A CLIENT'S DEATH. REVIEW OF THE COMPLAINT MANAGEMENT SYSTEM SHOWS THIS IS FALSE. THERE HAVE BEEN NO REPORTED DEATHS RELATED TO ANY MALFUNCTION WITH ANY TISPORT PRODUCT, INCLUDING THIS SPECIFIC COMPONENT. TISPORT FOLLOWS ITS COMPLAINT HANDLING PROCESS FOR FEEDBACK RECEIVED FROM THE FIELD. ANY COMPLAINT ASSOCIATED WITH A DEATH OR SERIOUS INJURY, OR FOR WHICH A DEATH OR SERIOUS INJURY COULD OCCUR IF A MALFUNCTION WERE TO RECUR, IS REPORTED AS AN MDR FOLLOWING FDA GUIDANCE MEDICAL DEVICE REPORTING FOR MANUFACTURERS. THE REPORT ALSO ALLEGES MULTIPLE EMPLOYEES WERE EITHER TERMINATED OR QUIT THEIR EMPLOYMENT AFTER VOICING THEIR CONCERN OF A PERCEIVED UNETHICAL PRACTICE. REVIEW OF TISPORT'S HR RECORDS SHOWS THIS IS ALSO FALSE. NO TISPORT EMPLOYEE HAS BEEN TERMINATED FOR THESE REASONS. QUALITY IS A CORNERSTONE OF OUR COMPANY AND WE STRIVE TO ENSURE THAT OUR PRODUCTS AND SERVICES LIVE UP TO OUR HIGH STANDARDS. IN MARCH 2019, IN ACCORDANCE WITH OUR PROCEDURES, A CORRECTIVE AND PREVENTIVE ACTION (CAPA (B)(4)) WAS OPENED TO INVESTIGATE AND IDENTIFY APPROPRIATE CORRECTIVE ACTIONS RELATED THE COMPONENT AT ISSUE IN THIS REPORT. AS PART OF THE CAPA PROCESS, AN HHE WAS USED TO ASSESS THE RISK OF THE PRODUCT ON THE MARKET AND FOUND THE OVERALL RISK TO THE END USER TO BE LOW. CORRECTIVE ACTIONS WERE IMPLEMENTED FOR THE PURPOSE OF INCREASING PRODUCT QUALITY STANDARDS AND ENSURING CUSTOMER SATISFACTION IN TISPORT PRODUCTS. COMPLAINTS ARE CONTINUOUSLY MONITORED AND EVALUATED AT A HEIGHTENED LEVEL OF SURVEILLANCE TO ENSURE RISK DOES NOT INCREASE TO AN UNACCEPTABLE LEVEL.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED CLAIMING SYSTEMIC QUALITY ISSUES WITH A CRITICAL COMPONENT, BACKREST HINGE, THAT REPORTEDLY LED TO MULTIPLE CUSTOMER COMPLAINTS AND QUALITY ISSUES. ALLEGATIONS CLAIM ISSUES OCCURED AFTER A CHANGE IN DESIGN AND SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547349 TILITE MANUAL WHEELCHAIR IOR TISPORT, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other