BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 7031452 · Received November 14, 2017

    Report

    Report Number
    8020893-2017-07779
    Event Type
    Death
    Date Received
    November 14, 2017
    Date of Event
    October 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. 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 IN THE INTENSIVE CARE UNIT (ICU) SECTION OF THE HOSPITAL IN (B)(6) A FIRE OCCURRED AND THERE WAS AN ALLEGED EXPLOSION OF AN UNIDENTIFIED COMPRESSOR. THE PATIENT THAT WAS ON AN 840 VENTILATOR EXPIRED SOMETIME LATER AFTER BEING REMOVED FROM THE FIRE AREA. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 8 INJURIES FROM THE INCIDENT. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809817 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death