BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZRA

    MDR report key: 8137921 · Received December 6, 2018

    Report

    Report Number
    3032618-2018-00010
    Event Type
    Injury
    Date Received
    December 6, 2018
    Report Date
    December 6, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET ALL SPECIFICATIONS AS ORDERED WHEN IT LEFT THE FACILITY. IN DISCUSSING THE SERIES OF EVENTS WITH THE END USER, IT WAS REVEALED THAT THE BOLT THAT DISASSEMBLED HAD BEEN RECENTLY REMOVED AND REASSEMBLED DUE TO MAINTENANCE PERFORMED ON THE CASTER BEARINGS BY AN INDEPENDENT TECHNICIAN. NO COMPANY NAME WAS PROVIDED FOR THIS TECHNICIAN, JUST HIS NAME AND THAT HE WAS SOMEONE WHO HAD ACCOUNTS THAT ALLOWED HIM TO GET PARTS.

    Description of Event or Problem · 1

    THE END USER CLAIMS THAT FOLLOWING MAINTENANCE TO HER CASTERS FROM AN INDEPENDENT 3RD-PARTY, SHE WAS USING HER WHEELCHAIR WHEN A BOLT DISASSEMBLED FROM THE FRONT CASTER, CAUSING THE WHEEL TO FALL OFF WITHOUT HER NOTICING. SHE CLAIMS THE ABRUPT STOP RESULTING FROM HER CASTER FORK CONTACTING THE GROUND CAUSED HER TO FALL FROM THE CHAIR AND BREAK HER FEMUR. THE INJURY REQUIRED SURGERY AND IMPLANTS. THE LATEST COMMUNICATION WITH THE CUSTOMER INDICATES SHE IS RECOVERING AND IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980212 ZRA WHEELCHAIR IOR TISPORT, LLC ZRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization