BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8699188 · Received June 14, 2019

    Report

    Report Number
    8010042-2019-00400
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    June 10, 2019
    Report Date
    January 12, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FSE (FIELD SERVICE ENGINEER). UPON OPENING THE UNIT, THE FSE IDENTIFIED THAT THE DC/DC PC BOARD HAD BEEN MODIFIED FOR THE HOSPITAL NURSE CALL SYSTEM, A CABLE WAS SOLDERED AND ATTACHED TO THE BACKSIDE OF THE ALARM OUTPUT CONNECTOR. THE MODIFIED PC BOARD WAS REPLACED AND SENT IN FOR INVESTIGATION. THE RETURNED DC/DC PC BOARD WAS TESTED BY US WITHOUT THE HOSPITAL MODIFICATION. WHEN INSTALLED INTO A TEST UNIT, THE DEVICE PASSES PRE-USE CHECK AND A SIMULATED VENTILATION SESSION DURING FOUR DAYS WITHOUT GENERATING ANY ALARMS. THE CAUSE OF THE REPORTED FAILURE CANNOT BE ESTABLISHED BY THE INVESTIGATION OF THE RETURNED PC BOARD, IT CAN HOWEVER NOT BE RULED OUT THAT THE MODIFICATION MADE AT THE HOSPITAL MAY HAVE CONTRIBUTED TO THE GENERATED ALARMS.

    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 PERSON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED TECHNICAL ERROR CODES FOR POWER ERROR AND OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492400 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA