BEUDAMED
    FDA Adverse Event Death Summary report: N

    980 VENTILATOR

    MDR report key: 6505422 · Received April 19, 2017

    Report

    Report Number
    8020893-2017-05737
    Event Type
    Death
    Date Received
    April 19, 2017
    Date of Event
    March 21, 2017
    Report Date
    February 6, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A BREATH DELIVERY (BD) POWER DISTRIBUTION PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND BD POWER CONTROLLER PCBA WERE RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENTS WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENTS WERE INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS; NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS AND FUNCTIONALITY TESTING WAS PERFORMED. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAULT WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY (BD) POWER DISTRIBUTION PRINTED CIRCUIT BOARD (PCB) AND BD POWER CONTROLLER PCB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR STOPPED CYCLING. THE CUSTOMER REPORTED THAT THERE WAS A DECREASE IN THE PATIENTS SPO2 (OXYGEN SATURATION VIA PULSE OXIMETRY). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AT THE TIME OF THE EVENT THE PATIENT WAS VENTILATED VIA BAG-VALVE-MASK, THE INTERVENTION LASTED 5 MINUTES AND THE PATIENTS SATURATION WAS RECOVERED TO 100%. ON (B)(6) 2017 SEVEN DAYS POST EVENT, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287581 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R