BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 8011844 · Received October 28, 2018

    Report

    Report Number
    8020893-2018-00523
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 4, 2018
    Report Date
    December 3, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521076891
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, MEDTRONIC HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPLACED THE BREATH DELIVERY (BD) XENA II PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR PASSED ALL TESTING PER MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. THE BD XENA II PCB WAS RETURNED FOR FAILURE INVESTIGATION. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED COMPONENT, NO ANOMALIES WERE OBSERVED. THE BD XENA II PCB WAS ATTACHED TO THE FAILURE INVESTIGATION TEST VENTILATOR FOR ANALYSIS. THE VENTILATOR WAS POWERED UP AND PASSED ALL TESTING WITH NO ERRORS RECORDED IN THE DIAGNOSTIC LOGS. THE VENTILATOR WAS PUT INTO VENTILATION MODE; HOWEVER, AFTER APPROXIMATELY 7 MINUTES ON VENTILATION, THE VENTILATOR GENERATED A ¿VENT INOPERATIVE¿ CONDITION. THE FAULT WAS ISOLATED TO THE BD OPERATING SOFTWARE HAVING BECOME CORRUPT. THE CORRUPT SOFTWARE WAS ERASED. SOFTWARE VERSION 4-070206-85-AC WAS RELOADED. AFTER COMPLETION OF SOFTWARE RELOAD, THE VENTILATOR PASSED ALL TESTING AND WAS PLACED IN NORMAL VENTILATION MODE FOR APPROXIMATELY 162 HOURS WITH NO ERRORS OR ALARMS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR ALARMED AND AFTER THE PATIENT COUGHED, VENTILATION STOPPED. THE UNIT GENERATED AN ERROR CODE WHICH RENDERED THE UNIT INOPERABLE. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853022 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840 10884521076891

    Patients

    Seq Age Sex Outcome Treatment
    1