BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC BABYPAC

    MDR report key: 962645 · Received December 13, 2007

    Report

    Report Number
    2182466-2007-00008
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 11, 2007
    Report Date
    December 6, 2007
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K043495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR IS MANUFACTURED BY SMITHS MEDICAL INTERNATIONAL, LTD. SMITHS MEDICAL PM, INC. IMPORTS THE VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL. SMITHS MEDICAL PM, INC. KITS A PATIENT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR. THE VENTILATOR HAS BEEN EVALUATED BY A SMITHS MEDICAL PM, INC. SERVICE TECHNICIAN. THE FAILURE AS DESCRIBED COULD NOT BE DUPLICATED UNDER NORMAL OPERATING CONDITIONS, HOWEVER, COULD BE DUPLICATED WHEN SIMULATING AN INADEQUATE SUPPLY OF GAS. THE OXYGEN SUPPLY HOSE, PATIENT CIRCUIT, AND REGULATOR USED AT THE TIME OF THE INCIDENT WERE NOT RETURNED WITH THE UNIT, SO WE COULD NOT EVALUATE IT. AS REPORTED, THE INCIDENT OCCURRED WHILE USING IT IN AN MRI, BEYOND THE 5000 GAUSS LINE. ACCORDING SMITHS MEDICAL INTERNATIONAL, LTD, THE BABYPAC HAS BEEN TESTED TO WORK IN THE CENTRE OF A 3 TESLA MR MACHINE, SO OPERATION IN THE 0.5 TESLA (5000 GAUSS) AREA SHOULD BE NO PROBLEM. CO TESTED ANOTHER NEW BABYPAC AT ALL THE SAME SETTINGS AND THE ONLY WAY HE COULD GET IT TO STOP CYCLING WAS BY GRADUALLY REDUCING THE INPUT PRESSURE IN STAGES TO BELOW 30 PS. HE TOOK THE PRESSURE DOWN IN STAGES AND TRIED TO SIMULATE THE STOPPING. FROM 60 PCI (OUR NORMAL OPERATING PRESSURE) DOWN TO 38PS THERE WAS NO VISIBLE EFFECT ON THE PERFORMANCE OF THE VENT, FROM 38 PS DOWN TO 30 PS THE PEAK INSPIRATORY AND PEEP PRESSURES WERE GRADUALLY REDUCING BUT THE VENT KEPT CYCLING. AT 28 PS THE VENT STOPPED CYCLING.

    Description of Event or Problem · 1

    PATIENT WAS BEING VENTILATED IN MRI. VENTILATOR ALLEGEDLY STOPPED CYCLING WHEN THE CLINICIAN INCREASED THE EXPIRATORY TIME SETTING TO ABOVE 2.0 SECONDS. PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC BABYPAC EMERGENCY/TRANSPORT VENTILATOR BTL SMITHS MEDICAL PM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention