BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILTOR

    MDR report key: 6182617 · Received December 16, 2016

    Report

    Report Number
    8020893-2016-03530
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND VERIFIED THE CUSTOMER REPORTED ISSUE. SE REPLACE THE BATTERY AND THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AN 840 VENTILATOR GENERATED A BATTERY INOPERABLE MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE ALARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833414 840 VENTILTOR CONTINUOUS VENTILATOR CBK COVIDIEN 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1