BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN BENNETT BB980 VENTILATOR SYSTEM

    MDR report key: 8115634 · Received November 28, 2018

    Report

    Report Number
    MW5081711
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    COVIDIEN / MEDTRONIC, FORMERLY NELLCOR PURITAN BENNETT, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN PB 980 VENTILATOR FELL OFF THE STAND WHILE IN TRANSPORT. THE VENTILATOR HAS A LOCKING MECHANISM IN THE BACK THAT HOLDS IT TO THE STAND. OVER TIME, AND WITH THE VIBRATION OF THE UNIT CAUSES THE LOCKING MECHANISM TO SHAKE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950262 PURITAN BENNETT BB980 VENTILATOR SYSTEM VENTILATOR CONTINUOUS FACILITY USE CBK COVIDIEN / MEDTRONIC, FORMERLY NELLCOR PURITAN BENNETT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1