BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21289276 · Received January 31, 2025

    Report

    Report Number
    3013095415-2025-00104
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 2, 2025
    Report Date
    January 20, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. VENTEC REVIEWED THE SYSTEM LOGS AND OBSERVED THAT IT HAD LOGGED MULTIPLE PATIENT CIRCUIT DISCONNECT ALARMS. VENTEC IS IN THE PROCESS OF EVALUATING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6: THROUGHOUT THE COURSE OF ITS INVESTIGATION, VENTEC WAS UNABLE TO IDENTIFY OR CONFIRM ANY DEVICE PERFORMANCE ISSUES WHICH MAY HAVE RESULTED IN THE VENTILATOR ALLEGEDLY "BLOWING EXTREMELY HARD", NOR WAS VENTEC ABLE TO DUPLICATE THE PATIENT CIRCUIT DISCONNECT ALARMS THAT HAD BEEN OBSERVED IN ITS ELECTRONIC RECORDS (SYSTEM LOGS). PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT DURING PATIENT USE, THE PATIENT ¿... WOKE UP TO THE VENT BLOWING EXTREMELY HARD. THE PATIENT STATES THAT HE TOOK THE MASK OFF AND TURNED THE VENT OFF." THE REPORTER ALSO ADVISED THAT THERE WERE NO ALARMS OBSERVED BY THE PATIENT OR THE CAREGIVER AT THE TIME OF THE EVENT. UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. VENTEC REVIEWED THE SYSTEM LOGS AND OBSERVED THAT IT HAD LOGGED MULTIPLE PATIENT CIRCUIT DISCONNECT ALARMS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495708 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male