BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7876415 · Received September 14, 2018

    Report

    Report Number
    8010042-2018-00485
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    July 26, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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).

    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 (B)(4). CONTACT PERON:(B)(4). NO SERVICE HAS BEEN REQUESTED BY THE USER FACILITY. IT HAS NOT BEEN COMMUNICATED IF ANY PARTS HAVE BEEN REPLACED. THE INVESTIGATION OF THE PROVIDED VENTILATOR LOGS CONFIRM THE REPORTED EVENT OF ALARMS FOR LOW O2 CONCENTRATION. THE LOGS DO NOT CONTAIN ANY TECHNICAL ERROR CODES INDICATING ANY VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. PRE-USE CHECK WAS SUCCESSFULLY PERFORMED PRIOR TO START OF VENTILATION. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ALARMS HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEASURED O2 CONCENTRATION DIFFERED FROM THE SET VALUE AND NOISE WAS GENERATED FROM THE VENTILATOR. 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
    720233 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1