BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER

    MDR report key: 149661 · Received February 19, 1998

    Report

    Report Number
    9680602-1998-00001
    Event Type
    Death
    Date Received
    February 19, 1998
    Date of Event
    January 16, 1998
    Report Date
    January 20, 1998
    Manufacturer
    PALL NEWQUAY LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ADMITTED ON 1/15/98 AT 1:20 PM AND PUT ON A VENTILATOR. REGULAR SUCTIONING AND LAVAGE WAS CARRIED OUT. AT 3:40 AM ON 1/16/98 THE PT WAS LAST ATTENDED TO AND SUCTIONED BY THE INHALATION THERAPIST. AT 4:15 AM THE NURSE ON DUTY PERFORMED SUCTIONING ON THE PT AND WHEN SHE CHECKED HIM AGAIN AT 5:30 AM THE PT HAD EXPIRED. THE INHALATION THERAPIST REPORTEDLY CHECKED THE FILTER AND SUSPECTED IT WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER HEAT & MOISTURE EXCHANGER BYD PALL NEWQUAY LTD. BB25F 706601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death