BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 976201 · Received February 27, 2007

    Report

    Report Number
    2021710-2007-00009
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    January 14, 2007
    Report Date
    February 27, 2007
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT AND THE EVALUATION OF THE DEVICE WAS DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "SPOKE WITH REP, HE STATED THAT SAID VENTILATOR WAS REPAIRED BY ONE OF HIS BIOMEDICAL TECH'S AND PUT BACK INTO SERVICE. ACCORDING TO REP, HIS BIOMED GUY FOUND A LEAK AROUND EXHALATION SIDE OF VENT WHICH WAS CAUSED BY A LOOSE EXHALATION VALVE. AN ATTEMPT WAS MADE TO GET MORE INFO ABOUT PT THAT WAS ON THE VENTILATOR IN QUESTION, WHEN MALFUNCTION OCCURRED. INFO IN QUESTION WAS PATIENTS SET PARAMETERS, PATIENTS CONDITION, AND PATIENTS PRESENTATION AT THE TIME OF INCIDENT. WHEN ASKING FOR SAID INFO, ALL NECESSARY PRECAUTIONS WERE TAKEN NOT TO VIOLATE PT CONFIDENTIALITY, AND HIPPA REGULATIONS. SAID INFO WAS NOT GIVEN DUE TO THE FACT THAT PERSON OF CONTACT WAS BIOMED AND HE WAS NOT SURE OF SAID INFO PERTANING TO PT. MY NAME AND NUMBER WAS LEFT WITH REP TO HAVE RESPIRATORY THERAPIST WHO KNOWS ABOUT SAID EVENT TO GIVE ME A CALL". THE USER FACILITY BIOMED EVALUATED THE DEVICE AND DETERMINED THAT THE ROOT CAUSE OF THE HIGH PEAK PRESSURE ALARM NOT SOUNDING WAS THAT THE ALARM SETTING WAS SET AT 65 CMH2O AND THE PATIENT'S PEAK INSPIRATORY PRESSURE NEVER WENT ABOVE 58 CMH2O. DURING THE EVALUATION OF THE DEVICE THE BIOMED FOUND THAT THE DEVICE FAILED THE LEAK TEST PORTION OF THE USER VERIFICATION TESTS. THIS WAS DUE TO A LOOSE EXHALATION VALVE BODY FLOW TRANSDUCER. THE USER FACILITY BIOMED REPAIRED THE UNIT AND RETURNED IT TO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT. "EVENT DESCRIPTION: VENTILATOR MALFUNCTION, PROBALLY OVER SEVERAL HOURS, CONTINUED TO SHOW PATIENTS TIDAL VOLUME, DID NOT ALARM, PATIENTS PEAK PRESSURE WENT TO 58, BREATHING LABORED. STAT ABG SHOWED CO2 INCREASE TO 73, PH 7.22, AND PO2 100. STANDARD INTERVENTION FOR HIGH PEAK PRESSURE WAS CARRIED OUT. SWITCHED OUT VENTILATOR, PT IMMEDIATELY IMPROVED PEAK PRESSURES AND DISTRESS. DEVICE USAGE PROBLEM: THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO". "OTHER ON 1/16/07: PERFORMED LEAK CHECK THROUGH UVT (USER VERIFICATION TEST) MODE. LARGE LEAK WAS EVIDENT AROUNG EXHALATION FLOW TRANSDUCER. WITH PEEP SET TO 10 CMH2O, SENSITIVITY SET TO 1 LPM THERE WAS ENOUGH FLOW BETWEN BREATH RATES TO CAUSE AUTO CYCLING. DID NOT ALARM BECAUSE PEAK PRESSURE DID NOT EXCEED PRESSURE LIMIT OF 65".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD VOLUME VENTILATOR CBK VIASYS RESPIRATORY CARE INC T-BIRD *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other