BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-S

    MDR report key: 7658439 · Received July 3, 2018

    Report

    Report Number
    8010042-2018-00321
    Event Type
    Death
    Date Received
    July 3, 2018
    Date of Event
    June 4, 2018
    Report Date
    January 29, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR DISTRIBUTOR. NO FAULT WAS FOUND EXCEPT FOR THE BATTERIES THAT WERE OLD AND SHOULD BE REPLACED. THE DEVICE LOGS WERE DOWNLOADED. EVALUATION OF THE DEVICE LOGS SHOW THAT THE PUC (PRE-USE CHECK) PRIOR TO AND AFTER THE GIVEN TIME FOR THE EVENT WAS FAILING BOTH O2 CELL/SENSOR TEST AND BATTERY SWITCH TEST. HOWEVER, NONE OF THE FAILING TESTS WILL AFFECT THE FLOW AND PRESSURE DELIVERY TO PATIENT. THERE IS NO ENTRY IN THE TECHNICAL LOG FOR THE GIVEN TIME OF THE EVENT. THE VENTILATION WAS STARTED EVEN THOUGH THE VENTILATOR FAILED THE PUC. THE VENTILATION WAS ON-GOING DURING 7 HOURS. A FEW ALARMS WERE SPORADICALLY GENERATED, INCLUDING THE ALARMS NOTICED IN THE VENTILATOR¿S ALARM HISTORY. THERE WERE NO FREQUENT ALARMS GENERATED. MINOR CHANGES IN VENTILATOR SETTINGS WERE PERFORMED BY THE USER. NO ALARMS WERE GENERATED THE LAST 3.5 HOURS OF VENTILATION EXCEPT FOR ONE RESPIRATORY RATE HIGH ALARM 2 MINUTES BEFORE STANDBY. THE ALARMS NOTICED IN THE VENTILATOR¿S ALARM HISTORY WERE CONFIRMED BUT THEY WERE SPORADIC GENERATED IN THE BEGINNING OF THE VENTILATION. THERE IS NOTHING IN THE DEVICE LOGS TO INDICATE A VENTILATOR MALFUNCTION FOR THE GIVEN TIME OF THE EVENT. RECEIVED INFORMATION FROM THE DIRECTOR OF THE HOSPITAL STATES THAT THE DEATH OF THE PATIENT WAS NOT ASSOCIATED WITH THIS EVENT. OUR CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION FOR THE GIVEN TIME OF THE 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 PERSON: (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED WHILE THE PATIENT WAS BEING VENTILATED. THE PATIENT SUFFERED A CARDIORESPIRATORY ARREST. THE VENTILATOR WAS CHANGED AND THE PATIENT STABILIZED. AFTER THIS THE ALARM HISTORY WAS CHECKED BY THE HOSPITAL STAFF AND IT WAS VERIFIED THAT IT CONTAINED ¿INSPIRATORY FLOW OUT OF RANGE¿ AND ¿PEEP LOW¿ ALARMS. THE PATIENT DIED LATER WHILE CONNECTED TO ANOTHER VENTILATOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501734 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening