BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SLCD12

    MDR report key: 18475644 · Received January 9, 2024

    Report

    Report Number
    3013145340-2024-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    April 18, 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 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. NO EVIDENCE OF THE DEVICE MALFUNCTION AVAILABLE. HOWEVER, THE IF THERE WAS A MALFUNCTION, IT CAUSED 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

    IT WAS REPORTED BY THE CUSTOMER THAT THE INCUBATOR HAS SOME PORTS NOT WORKING PROPERLY. THE DEVICE WAS SENT BACK TO THE DISTRIBUTOR BUT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649959 STRYKER SLCD12 AUTOREADER INCUBATOR FRC TERRAGENE S.A. STRYKER SLCD12 SLCD120821 07798164678175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown