BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL

    MDR report key: 525542 · Received May 7, 2004

    Report

    Report Number
    525542
    Event Type
    Death
    Date Received
    May 7, 2004
    Date of Event
    May 5, 1904
    Manufacturer
    PALL MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR PRESSURE LIMIT ALARM WENT OFF. RESPIRATORY THERAPIST AND THE R.N. RESPONDED TO STAT CALL. PT BAGGED. PHYSICIAN RESPONDED. TRACH CHANGED-NO RETURN VOLUMES ON VENTILATOR. WHEN THE PALL FILTER WAS REMOVED, THE VENTILATOR WORKED. PT WAS PULSELESS. COMPRESSION INITIATED. DRUGS ADMINISTERED. ACLS PROTOCOL FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER CAH PALL MEDICAL 50-1389 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death PURITAN BENNETT VENTILATOR 7200, 1904,| 72" UNI-LIMB RC VENTILATOR CIRCUIT, 1904,| MISTRY-NEB NEBULIZER CAT #002038 AIRLIFE ALL, 1904| TRACH TUBE SHILEY B DFEN LOW PRESS DISPOSABLE,1904