BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7690401 · Received July 16, 2018

    Report

    Report Number
    8010042-2018-00360
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 19, 2018
    Report Date
    January 28, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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).

    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 FACILITY PERFORMS OWN SERVICE AND HAS NOT REPORTED BACK OF ANY REPLACED PARTS. THE VENTILATOR'S LOGS WERE HOWEVER SENT FOR EVALUATION. THE LOGS CONTAIN 3 PANEL DISCONNECT ALARMS AND ONE SHUTDOWN ON THE MOST PROBABLE DATE OF EVENT WHICH CORRESPOND TO THE REPORTED ISSUE. THE SHUTDOWN WAS NOT PRECEDED BY A NORMAL SETTING OF THE VENTILATOR INTO THE STANDBY MODE BUT IT WAS DONE BY USING THE ON/OFF SWITCH. IT WAS LOGGED AS A NORMAL SHUTDOWN BY THE USER WITH NO TECHNICAL ERROR INDICATING THAT THERE WAS NO FAULT WITH THE ON/OFF SWITCH. THE PANEL DISCONNECTED ALARM INDICATES A COMMUNICATION FAILURE BETWEEN THE USER INTERFACE AND THE PATIENT UNIT. IT WILL LEAD TO A LOSS OF DISPLAYED INFORMATION ON THE USER INTERFACE BUT WILL NOT LEAD TO STOP OF VENTILATION. THE USER INTERFACE WILL BLANK OUT BUT VENTILATION CONTINUES UNABATED WITH THE SET PARAMETERS PRIOR TO THE ALARM. THE LOGS SHOW THAT AFTER THE OCCURRENCE THE PANEL DISCONNECT ALARMS, THERE ARE NO OTHER ALARMS THAT INDICATE THAT VENTILATION STOPPED. THE CONCLUSION IN THE MATTER IS THAT THERE WAS NO STOP OF VENTILATION BUT ONLY BLANKING OUT OF THE SCREEN DUE TO A COMMUNICATION FAILURE BETWEEN THE USER INTERFACE AND THE PATIENT UNIT. THE BLANKING OUT OF THE SCREEN IS WHAT WAS PERCEIVED AS THE VENTILATOR SHUTTING DOWN WHILE ON A PATIENT. THE TRUE CAUSE OF THE ALARMS HAS NOT BEEN DETERMINED. THE FACILITY PERFORMS OWN SERVICE AND HAS NOT REPORTED BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR SHUTDOWN WHILE IT WAS CONNECTED TO A PATIENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531127 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1