BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8394569 · Received March 6, 2019

    Report

    Report Number
    8010042-2019-00138
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 12, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS REPORTED BY THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED REGARDING THE SERVICE MEASURE OR IF ANY PART WAS CHANGED. NO NEW EVENTS ON THIS VENTILATOR HAVE BEEN REPORTED UNTIL THIS DATE. AN EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS THE REPORTED EVENT. AS NO GOODS WERE RETURNED FOR INVESTIGATION AND NO INFORMATION REGARDING THE SERVICE MEASURES, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE 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 (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, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186803 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1