BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PB540 VENTILATOR

    MDR report key: 3935726 · Received June 23, 2014

    Report

    Report Number
    8020893-2014-01471
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    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) EVALUATED THE UNIT, AND OBSERVED THAT THE INSPIRATORY CONICAL FITTING HAS BEEN PULLED OUT OF THE VENTILATOR, WITHOUT CAUSING DAMAGE. THE CSE REINSTALLED THE CONICAL FITTING. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, A PB540 VENTILATOR INSPIRATORY PORT CAME LOOSE/DISLODGED FROM THE HOUSING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364690 PB540 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND PB540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention