BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTILATOR, PEDIATRIC (GENERAL)

    MDR report key: 606832 · Received May 20, 2005

    Report

    Report Number
    2020676-2005-00001
    Event Type
    Injury
    Date Received
    May 20, 2005
    Report Date
    May 20, 2005
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "THE INSPIRATOR TIME ON THE VENT (VENTILATOR) WAS SET FOR .3. THE PT (PATIENT) STARTED HAVING RESP. (RESPIRATORY) DISTRESS DURING THE WEANING PROCESS. THE RESP THERAPIST (RESPIRATORY THERAPIST) OBSERVED THE VENTILATOR AUTOMATICALLY CHANGE THE INSPIRATORY TIME TO .75: IT IS UNK (UNKNOWN) HOW LONG THE VENT WAS MALFUNCTIONING, BUT BASED ON THE PT'S (PATIENT'S) PROGRESS OF WEANING, IT APPEARS THAT THE RT (RESPIRATORY THERAPIST) OBSERVED THE MALFUNCTION SHORTLY AFTER THE VENT STARTED HAVING PROBLEMS. AS A RESULT, THE PT (PATIENT) DEVELOPED A PNEUMOTHORAX AND REQUIRED INSERTION OF A CHEST TUBE." REPORTED VENTILATOR SETTINGS: FIO2: 35% IMV 30, P/P 25/5, IMP. 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, PEDIATRIC (GENERAL) ALL CONFIGURATIONS CBK SECHRIST INDUSTRIES, INC. IV-100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention