BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 18434242 · Received January 3, 2024

    Report

    Report Number
    3013145340-2024-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    August 15, 2022
    Report Date
    January 3, 2024
    Manufacturer
    TERRAGENE S.A
    Product Code
    FRC
    UDI-DI
    07798164678175
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATHS OR SERIOUS INJURIES WERE INFORMED. DEVICE MALFUNCTION CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE DEVICE'S MONITORING EFFECTIVENESS, SINCE IT WOULD NOT BE ABLE TO PROCESS BIOLOGICAL INDICATORS. IF THIS WERE TO RECUR, THE LACK OF BIOLOGICAL INDICATORS PROCESSING COULD AFFECT THE LOAD RELEASE, WHICH COULD CONTRIBUTE TO A SERIOUS INJURY DUE TO LACK OF STERILE MATERIAL.

    Description of Event or Problem · 0

    ACCORDING TO THE DISTRIBUTOR REPRESENTATIVE, THE AUTOREADER INCUBATOR WOULD NOT GET TO THE WORKING TEMPERATURE, WHICH WOULD NOT LET THE AUTOREADER START ANY BIOLOGICAL INDICATOR INCUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436080 STRYKER AUTO-READER INCUBATOR FRC TERRAGENE S.A STRYKER SLCD13 UNKNOWN 07798164678175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown