BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 5183302 · Received October 28, 2015

    Report

    Report Number
    8020893-2015-01284
    Event Type
    Injury
    Date Received
    October 28, 2015
    Report Date
    December 20, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER VERIFIED CUSTOMER COMPLAINT AND REPLACED THE BREATH DELIVERY UNIT CENTRAL PROCESSING UNIT (BDU CPU). THE UNIT THEN CHECKED TO THE MANUFACTURER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED AND THE TECHNICIAN FOUND THAT THE REPORTED PROBLEM COULD NOT BE DUPLICATED. NO FAILURE WAS DETECTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR SHUT DOWN. THE PATIENT WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715923 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention