BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUPAC TRANSPAC WITH INTEGRATED ALARM

    MDR report key: 3082930 · Received April 22, 2013

    Report

    Report Number
    2183502-2013-00169
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    BTL
    PMA / PMN Number
    K030803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING CONFIRMED THE DEVICE STOPPED OPERATING IN THE MIDDLE OF THE TEST. THE DEMAND DETECTOR WAS DISCONNECTED FORM THE NRV AND THE UNIT BEGAN TO CYCLE IMMEDIATELY. A LEAK WAS OBSERVED FORM THE DEMAND DETECTOR. VISUAL INSPECTION WAS UNABLE TO FIND ANY DAMAGE TO THE DEMAND DETECTOR OR INTERNAL PARTS. FOLLOWING REMOVAL OF THE DEMAND DETECTOR, THE UNIT PASSED ALL FUNCTION AND DELIVERY TESTING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH A PT WHEN THE DEVICE BECAME NON-FUNCTIONAL AND STOPPED VENTILATING THE PT. ACCORDING TO THE REPORTER, THE PT REQUIRED AN ALTERNATIVE MEANS OF VENTILATION. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171533 PNEUPAC TRANSPAC WITH INTEGRATED ALARM BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL MD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK