BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 20219397 · Received September 14, 2024

    Report

    Report Number
    3013095415-2024-00681
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC WILL PERFORM AN EVALUATION OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6: VENTEC DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS FOR ANALYSIS WHERE IT WAS CONFIRMED THAT IT HAD POWERED OFF UNEXPECTEDLY, BOTH DURING THE EVENT AS WELL AS PREVIOUS TO THE EVENT (AS DESCRIBED BY THE PATIENT'S MOTHER). DURING THE DEVICE EVALUATION VENTEC WAS ALSO ABLE TO DUPLICATE THE REPORTED ISSUE, OBSERVING THAT THE DEVICE REBOOTED BY ITSELF DURING TESTING. VENTEC REPLACED THE CONTROL BOARD, INTERNAL FLOW TRANSDUCER (IFT) AND IFT CABLE TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE CONTROL BOARD, IFT AND IFT CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY POWERED OFF TWICE DURING USE. THE REPORTER ADVISED THAT THERE WERE NO ALARMS PRIOR TO THE DEVICE SUDDENLY POWERING OFF AND THAT IT WAS PLUGGED IN TO AN AC POWER SOURCE. THE PATIENT¿S NURSE WAS PRESENT AND MANUALLY VENTILATED THE PATIENT UNTIL THE RESPIRATORY THERAPIST (RT) ARRIVED AT THEIR BEDSIDE. THE RT THEN PLACED THE PATIENT BACK ON THE VENTILATOR AND IT POWERED ON WITHOUT ANY ISSUES. THE PATIENT¿S MOTHER ALERTED PERSONNEL THAT THE DEVICE HAD BEEN INTERMITTENTLY POWERING OFF ON ITS OWN, BUT NO FURTHER SPECIFICS WERE AVAILABLE. THE PATIENT WAS EVENTUALLY PLACED ON A DIFFERENT VENTILATOR FOR SUPPORT. THERE WERE NO REPORTS OF HARM TO THE PATIENT, HOWEVER, THE SITUATION REQUIRED MEDICAL INTERVENTION IN ORDER TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT (MANUAL VENTILATION). VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER(S) TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130263 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention