BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE JET VENTILATOR

    MDR report key: 4651 · Received July 31, 1992

    Report

    Report Number
    4651
    Event Type
    Injury
    Date Received
    July 31, 1992
    Date of Event
    April 25, 1992
    Report Date
    June 30, 1992
    Manufacturer
    BUNNELL, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A LEAK WAS HEARD FROM VENTILATOR CIRCUIT DURING ROUTINE CHECK. HEART RATE INCREASED TO 200. THE PEEP DECREASED TO +8, AND PIP DECREASED TO 38-39. SMALL LEFT UPPER LOBE PNEUMO-THORAX WAS NOTED ON FILM. THE VENTILATOR DID NOT ALARM UNTIL AFTER THE INTERVENTION WAS BEGUNINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: OTHER, OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE JET VENTILATOR CBK BUNNELL, INC. 203 (VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention