BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUPAC VENTIPAC

    MDR report key: 3843622 · Received May 27, 2014

    Report

    Report Number
    2183502-2014-00344
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 23, 2014
    Manufacturer
    SMITHS MEDICALINTERNATIONAL, LTD
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE STOPPED CYCLING WHILE ON A PT. THE REPORT STATES THAT THE PT WAS BEING TRANSPORTED TO MRI WHEN THE DEVICE STOPPED, REPORTEDLY, WITHOUT ALARMING. THE PT WAS MANUALLY VENTILATED WITH INCREASED POSITIVE END-EXPIRATORY PRESSURE (PEEP) TO RETURN THE PT'S SPO2 TO WITHIN THE NORMAL RANGE. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311768 PNEUPAC VENTIPAC VENTILATOR, EMERGENCY, POWERED BTL SMITHS MEDICALINTERNATIONAL, LTD 130003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention