BEUDAMED
    FDA Adverse Event Death Summary report: N

    980 VENTILATOR

    MDR report key: 6560617 · Received May 11, 2017

    Report

    Report Number
    8020893-2017-06064
    Event Type
    Death
    Date Received
    May 11, 2017
    Date of Event
    April 11, 2017
    Report Date
    May 21, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PB980 VENTILATOR WAS RETURNED TO MEDTRONIC FOR FAILURE INVESTIGATION. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED DEVICE, NO ANOMALIES WERE OBSERVED. THE VENTILATOR LOGS WERE RECEIVED AND REVIEWED. THE REPORTED EVENT BY (B)(6) THAT THE PB980 GENERATED ALARMS AND STOPPED CYCLING WAS REPLICATED. IN RESPONSE TO A NON-FUNCTIONAL BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU), THE VENTILATOR ACTIVATED BOTH VISUAL AND AUDIO ALARMS. THE PNEUMATICS SUBSYSTEM SWITCHED TO SAFE MODE AND THE SAFETY VALVE OPENED. THE CAUSE OF THE FAILURE WAS AN INTERMITTENT NON-FUNCTIONAL BD CPU. PRODUCT DOES NOT MEET MEDTRONIC SPECIFICATION. THE FAILURE RELATES TO THE REPORTED COMPLAINT EVENT MADE BY THE CUSTOMER. NO CORRECTIVE ACTION IS REQUIRED, THE EVENT WILL BE INCLUDED IN PRODUCT TRENDING AND MONITORING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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, A 980 VENTILATOR GENERATED AN ALARM, STOPPED CYCLING AND THEN SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT EXPIRED APPROXIMATELY 45 MINUTES AFTER THE REPORTED EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING THE EVENT HAS NOT BEEN PROVIDED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS HOWEVER, WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Description of Event or Problem · 1

    MEDWATCH MFR REPORT # 8020893-2017-06290 WAS INADVERTENTLY SUBMITTED. IT IS A DUPLICATE OF THIS REPORT. REFERENCE UF/IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342949 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R