BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 146803 · Received December 30, 1997

    Report

    Report Number
    146803
    Event Type
    Other
    Date Received
    December 30, 1997
    Date of Event
    September 12, 1997
    Report Date
    September 25, 1997
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNSTABLE PEEP VALUE DISPLAYED ON HFJV READOUT. PEEP DRIFTED HIGHER OVER THREE HR PERIOD. PEEP SETTING ON CONVENTIONAL VENTILATOR (SECHRIST) WAS ADJUSTED TOO LOW BASED ON HFJV'S INACCURATE PEEP DISPLAY. THERAPIST CORRECTED PROBLEM BY REPLACING THE PATIENT BOX. PATIENT BOX MALFUNCTION WAS VERIFIED BY BIOMEDICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HIGH FREQUENCY VENTILATOR LSZ BUNNELL INC. 203 (LIFE PULSE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Other