BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7926080 · Received October 2, 2018

    Report

    Report Number
    8010042-2018-00518
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 PERSON: (B)(4). THE USER FACILITY HAS NOT REQUESTED ANY SERVICE OF THE VENTILATOR. IT HAS NOT BEEN COMMUNICATED IF ANY PARTS HAVE BEEN REPLACED. THE INVESTIGATION OF THE PROVIDED VENTILATOR LOGS CONFIRMS ALARMS FOR LOW O2 CONCENTRATION. THE LOGS DO NOT CONTAIN ANY TECHNICAL ERROR CODES INDICATING VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. PRE-USE CHECK WAS SUCCESSFULLY PERFORMED PRIOR TO THE START OF VENTILATION. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ALARMS HAS NOT BEEN DETERMINED.

    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

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CONNECTED TO A PATIENT, THE DELIVERED O2 CONCENTRATION WAS DRIFTING. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768260 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1