BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21590519 · Received March 12, 2025

    Report

    Report Number
    3013095415-2025-00172
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 12, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC.
    Product Code
    CBK
    UDI-DI
    00855573007877
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF IT CYCLING POWER BY ITSELF WAS CONFIRMED. VENTEC DOWNLOADED THE DEVICE¿S ELECTRONIC RECORDS (SYSTEM LOGS) AND OBSERVED MULTIPLE ABNORMAL POWER-ONS INDICATIVE OF A DEVICE REBOOT. DURING TESTING, HOWEVER, VENTEC WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. VENTEC THEN PERFORMED A DEEPER ANALYSIS OF ITS SYSTEM LOGS AND OBSERVED THAT FOR THE FIRST TWO ABNORMAL POWER-ONS, THE LOGS SHOWED THAT THE DEVICE WAS OPERATING SOLELY ON ITS INTERNAL BATTERY WHICH HAD ALMOST NO CHARGE, EXPLAINING WHY THE DEVICE HAD SHUT OFF "UNEXPECTEDLY". THE DEVICE MAY HAVE HAD EXTERNAL BATTERIES ATTACHED, BUT THOSE BATTERIES DID NOT HAVE ENOUGH CHARGE TO OPERATE / COMMUNICATE WITH THE DEVICE. AFTER THE SECOND, BUT PRIOR TO THE THIRD ABNORMAL START, THE DEVICE WAS ALLOWED TO SIT IDLE AND NOT CONNECTED TO POWER FOR ENOUGH THAT IT COULD NO LONGER MAINTAIN DATE / TIME. ONCE THE DEVICE WAS POWERED ON, THE LOGS INDICATED IT WAS NOT CONNECTED TO EXTERNAL POWER AND NEITHER THE INTERNAL OR EXTERNAL BATTERIES HAD ENOUGH CHARGE TO MAINTAIN DEVICE OPERATION, EXPLAINING WHY THE DEVICE SHUT OFF "UNEXPECTEDLY" FOR THE THIRD TIME. THE FOURTH, AND FINAL, ABNORMAL POWER-ON REGISTERED HAVING EXTERNAL POWER ATTACHED. THE LOGS INDICATED THAT THE DEVICE OPERATED NORMALLY AND WAS SHUT DOWN MANUALLY. THE NEXT POWER-ON WAS A NORMAL START, INDICATING THAT THE DEVICE WAS FUNCTIONING AS EXPECTED. THE VOCSN CLINICAL AND TECHNICAL MANUAL [P.11] STATES THE FOLLOWING: "WARNING: CHECK THE BATTERIES AND EXTERNAL POWER SUPPLY REGULARLY TO ENSURE FUNCTIONALITY. VOCSN POWER FAILURE MAY INTERRUPT VENTILATION THERAPY AND RESULT IN PATIENT HARM OR DEATH.". THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE POWER CYCLES WHEN ANY POWER SOURCE IS APPLIED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993072 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC. V+PRO, ENGLISH 00855573007877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown