BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC VENTIPAC

    MDR report key: 1947891 · Received December 30, 2010

    Report

    Report Number
    2183502-2010-00615
    Event Type
    Death
    Date Received
    December 30, 2010
    Report Date
    December 27, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTL
    PMA / PMN Number
    K030803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED FOR EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE PRODUCT WAS IN USE ON A PATIENT DURING AN MRI; REPORTEDLY, THE DEVICE STOPPED FUNCTIONING. THE DEVICE WAS PLACED BETWEEN THE PATIENT'S LEGS DURING THE SCAN. THE REPORTER STATED THE PATIENT WAS "THRASHING". DURING THE SCAN, IT WAS NOTICED THAT THE PATIENT'S CHEST WAS NOT RISING. THE STAFF IN ATTENDANCE REPORTS THAT THEY DID NOT HEAR THE UNIT ALARM. THE PATIENT IS REPORTED TO HAVE EXPIRED SEVERAL DAYS LATER. THE FACILITY REPORTED THAT THEY DO NOT BELIEVE THE DEVICE IS THE CAUSE OF THE PATIENT DEATH. THE EVENT WAS REPORTED AS PART OF THEIR INTERNAL INVESTIGATION, THEY ARE INVESTIGATING ALL POTENTIAL CAUSES AND REQUESTED THAT THE DEVICE BE EVALUATED BY THE MANUFACTURER. BIO-MEDICAL ENGINEERING AT THE FACILITY HAS EVALUATED THE DEVICE AND COULD FIND NO FAILURE OR FAULT WITH THE UNIT. ADDITIONALLY, THEY TESTED THE DEVICE IN THE MRI SUITE AND IT OPERATED ACCORDINGLY.

    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 UNK Death