BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8023432 · Received October 31, 2018

    Report

    Report Number
    8010042-2018-00579
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 4, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    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

    THE USER FACILITY PERFORMS SERVICE OF THEIR VENTILATORS BY THEMSELVES AND DID NOT REQUEST ANY SERVICE. IT HAS NOT BEEN COMMUNICATED IF ANY PARTS WERE REPLACED. THE INVESTIGATION OF THE PROVIDED VENTILATOR LOGS CONFIRMS 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 VENTILATION WAS STARTED. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ALARMS HAS NOT BEEN DETERMINED. 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

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH AND LOW O2 CONCENTRATION. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862882 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1