BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARAPAC 'MEDIC' (K020899)

    MDR report key: 537830 · Received August 6, 2004

    Report

    Report Number
    9611178-2004-00002
    Event Type
    Death
    Date Received
    August 6, 2004
    Report Date
    August 2, 2004
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL
    Product Code
    BTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE TRANSFER OF A PT IN AN AMBULANCE, WHERE THE AMBULANCE CREW STATE THAT THE VENTILATOR FUNCTIONED NORMALLY, TO THE HOSP, AT WHICH A DR ALLEGED THAT THE VENTILATOR FAILED RESULTING IN AN UNSUCCESSFUL RESUSCITATION AFTER WHICH THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAPAC 'MEDIC' (K020899) MEDICAL GAS VENTILATOR (EMERGENCY) BTL SMITHS MEDICAL INTERNATIONAL 2D 03/06/406

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death