BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SLCD12

    MDR report key: 18397481 · Received December 27, 2023

    Report

    Report Number
    3013145340-2023-00004
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    October 28, 2021
    Report Date
    December 26, 2023
    Manufacturer
    TERRAGENE S.A
    Product Code
    FRC
    UDI-DI
    07798164678175
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED. NO EVIDENCE OF INCUBATOR'S MALFUNCTION. MOST PROBABLE CAUSE OF THE POSITIVE RESULTS ARE AN INEFFECTIVE STERILIZATION PROCESS OR BI MALFUNCTION. AS NO FURTHER INFORMATION WAS PROVIDED, WE CONSIDER THERE'S A POSSIBILITY OF BI MALFUNCTION, WHICH MAY CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE STERILIZATION PROCESS MONITORING EFFECTIVENESS WHICH COULD CONTRIBUTE TO DELAY PATIENT TREATMENT AND, HENCE, TO A SERIOUS INJURY.

    Description of Event or Problem · 0

    PERSONNEL OF THE UNIVERSITY OF UTAH INDICATED THAT BIOLOGICAL INDICATORS KEPT SHOWING POSITIVE RESULTS AFTER THE STERILIZATION PROCESS. THEY MENTIONED THAT TECHNICIANS MADE MULTIPL ATTEMPTS TO REPAIR THE STERILIZER BUT TO NO AVAIL AND CONCLUDED THAT THE INCUBATOR WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296650 STRYKER SLCD12 AUTO-READER INCUBATOR FRC TERRAGENE S.A STRYKER SLCD12 UNKNOWN 07798164678175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown