BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7812863 · Received August 24, 2018

    Report

    Report Number
    8010042-2018-00446
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THIS BOARD CONTAINS ELECTRONICS WHICH INCLUDE MICROPROCESSOR FOR CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION OF THE DEVICE. THE PC-BOARD WAS INSTALLED IN A VENTILATOR FOR SIMULATED USE TESTING. THE PRE-USE CHECK FAILED THE INTERNAL LEAKAGE TEST SINCE THE SAFETY VALVE IS OPEN, WHEN IT WAS EXPECTED TO BE CLOSED. THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A SHORT CIRCUIT IN A CAPACITOR THAT IS PART OF THE ELECTRONICS FOR SAFETY VALVE FUNCTION. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS A MATCHING EVENT AT 16:10 ON THE REPORTED DATE. 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

    IT WAS REPORTED THAT WHEN TURNING ON THE UNIT, A TECHNICAL ALARM REGARDING POWER ERROR AND SAFETY VALVE OPEN WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654478 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1