BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 18474940 · Received January 9, 2024

    Report

    Report Number
    3013145340-2024-00017
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    February 27, 2023
    Report Date
    January 9, 2024
    Manufacturer
    TERRAGENE S.A
    Product Code
    FRC
    UDI-DI
    07798164678175
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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. 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 IF IT WERE TO RECUR DUE TO LACK OF STERILE MATERIAL.

    Description of Event or Problem · 0

    ACCORDING TO THE USER, THE AUTOREADER INCUBATOR WAS NOT WORKING DURING TESTING. PRODUCT WAS SCRAPPED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605181 STRYKER AUTO-READER INCUBATOR FRC TERRAGENE S.A STRYKER SLCD12 SLCD124820 07798164678175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown