BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HBO VENT, MODEL HV-500A

    MDR report key: 1935806 · Received December 3, 2010

    Report

    Report Number
    2020676-2010-00033
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 3, 2010
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K832508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED AND IS CURRENTLY UNDER EVALUATION. RESULTS TO BE PROVIDED WHEN COMPLETED.

    Description of Event or Problem · 1

    DURING THE DECOMPRESSION STATE IN THE CHAMBER THE EXHALATION PHASE ON THE HBO VENTILATOR STUCK CAUSING IT TO STAY CLOSED. THIS IN TURN CAUSED THE VENT TO NOT CYCLE OVER THE EXHALATION RESULTING IN PROLONGED ELEVATED AIRWAY PRESSURES. PERFUSIONIST REPORTED HE IS NOT SURE WHICH PATIENT USED WITH WHICH VENT. TREATMENT DATE: (B)(6) 2010. TREATED FOR CARBON MONOXIDE POISONING. NO CARDIAC EMBARRASSMENT (SATURATION LEVELS DID NOT DROP OFF). THE PROBLEM WAS CAUGHT QUICKLY AND VENTILATOR WAS CUT-OFF AND THEN WAS MANUALLY VENTILATED. THE VENTILATOR WAS IMMEDIATELY PULLED OUT OF SERVICE.

    Additional Manufacturer Narrative · 2

    DEVICE RECEIVED AND IS CURRENTLY UNDER EVALUATION. RESULTS TO BE PROVIDED WHEN COMPLETED.

    Description of Event or Problem · 2

    DURING THE DECOMPRESSION STATE IN THE CHAMBER THE EXHALATION PHASE ON THE HBO VENTILATOR STUCK CAUSING IT TO STAY CLOSED. THIS IN TURN CAUSED THE VENT TO NOT CYCLE OVER THE EXHALATION RESULTING IN PROLONGED ELEVATED AIRWAY PRESSURES. PERFUSIONIST REPORTED HE IS NOT SURE WHICH PATIENT USED WITH WHICH VENT. TREATMENT DATE: (B)(6) 2010. TREATED FOR CARBON MONOXIDE POISONING. THE PATIENT DID DEVELOP ARRYTHMIA CARDIAC AND HAD TO BE MANUALLY VENTILATED WHEN SHE WAS BROUGHT OUT OF THE CHAMBER SO THAT HER HEART RATE COULD BE BROUGHT BACK UP. HER HEART RATE WENT DOWN TO 50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HBO VENT, MODEL HV-500A NONE CBK SECHRIST INDUSTRIES, INC. 500A VENT

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention
    2 74 YR