BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WTL198-0079

    MDR report key: 18477795 · Received January 9, 2024

    Report

    Report Number
    3013145340-2024-00022
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    October 5, 2023
    Report Date
    January 9, 2024
    Manufacturer
    TERRAGENE S.A
    Product Code
    JOJ
    UDI-DI
    07798164677468
    PMA / PMN Number
    K163646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO REPORTED MEDICAL INTERVENTIONS, SURGICAL DELAYS, OR ANY ADVERSE CONSEQUENCES FOR PATIENT AND/OR USER WITH THIS EVENT. INVESTIGATION SUGGESTED THAT THE POWER SUPPLY WAS DAMAGED. THIS MALFUNCTION COULD CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE STERILIZATION PROCESS MONITORING EFFECTIVENESS BY NOT BEING AVAILABLE FOR STERILIZATION MONITORING WITH THE RAPID BIS, DELAYING THE RELEASE OF THE STERILIZATION LOADS, WHICH COULD CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCUBATOR LIGHTS WERE TURNING ON AND OF AND IT WAS BEEPING. IT COULD NOT BE USE FOR INCUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553636 WTL198-0079 AUTO-READER INCUBATOR JOJ TERRAGENE S.A WTL198-0079 WTL19800794020 07798164677468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown