BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8120288 · Received November 30, 2018

    Report

    Report Number
    8010042-2018-00649
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 24, 2018
    Report Date
    April 29, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 PERON: (B)(4). COMPLAINT INVESTIGATION OF THE REPORTED EVENT HAS BEEN FINALIZED. THE DEVICE CONTROL PC(PRINTED CIRCUIT)BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED TECHNICAL ERROR ALARMS WERE REPRODUCED DURING OUR LABORATORY TEST. THE LOG REVIEW INDICATES A CORRUPTION OF DATA WHICH CAUSES THE BREATHING SUBSYSTEM TO REBOOT. HOW THE CONTROL PC BOARD GOT IN THIS CONDITION HAS NOT BEEN ESTABLISHED BY THIS INVESTIGATION. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT.

    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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES, INDICATING COMMUNICATION ERROR. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961253 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1