BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8343392 · Received February 15, 2019

    Report

    Report Number
    8010042-2019-00093
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING SERVICE BY HOSPITAL'S BIOMED TECHNICIAN, IT WAS NOTICED THAT THE NEW PC (PRINTED CIRCUIT) BOARD HAD AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR FIELD SERVICE ENGINEER, THE HOSPITALS BIOMED TECHNICIAN CHANGED SEVERAL PARTS IN THE VENTILATOR AND A TECHNICAL ERROR INDICATING A COMMUNICATION ERROR OR PRINTED CIRCUIT (PC) BOARD STARTUP FAILURE WAS GENERATED. OUR FIELD SERVICE ENGINEER CONCLUDED THAT THIS WAS CAUSED BY A INCOMPATIBILITY BETWEEN PARTS AND AFTER SOFTWARE UPGRADE THE VENTILATOR WORKED AS INTENDED. AFTER THE VENTILATOR UNIT WAS CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, IT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE CONCLUSION IN THIS MATTER IS THAT THE PC BOARD FAILED WITH THE GENERATED TECHNICAL ERROR DUE TO A SOFTWARE INCOMPATIBILITY OR ANY OTHER BOARD SWITCHING ISSUE WHEN THE BIOMED TECHNICIAN WAS SWITCHING PC BOARDS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135346 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1