BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC VENTIPAC

    MDR report key: 2559962 · Received April 27, 2012

    Report

    Report Number
    2183502-2012-00157
    Event Type
    Death
    Date Received
    April 27, 2012
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTL
    PMA / PMN Number
    K030803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC VENTIPAC BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL INTERNATIONAL LTD. V200D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death