BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PB540 VENTILATOR

    MDR report key: 3874057 · Received May 28, 2014

    Report

    Report Number
    8020893-2014-01288
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K082966
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE CSE CONDUCTED PERFORMANCE VERIFICATION TESTING (PVT) ON THE DEVICE, ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    COVIDEN RECEIVED INFO FROM A CUSTOMER IN THE USA STATING THAT WHILE IN USE ON A PT THE DISPLAY ON A PB540 VENTILATOR WAS ERRATIC (GARBLED). THE PT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PT WAS NOT HARMED OR INJURES AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314568 PB540 VENTILATOR CBK COVIDIEN PB540

    Patients

    Seq Age Sex Outcome Treatment
    1