BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12607121 · Received October 11, 2021

    Report

    Report Number
    3013095415-2021-00508
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    December 18, 2019
    Report Date
    October 3, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED O2 CONCENTRATION ALARM COULD NOT BE DUPLICATED.. THE DEVICE'S ELECTRONIC RECORDS WERE DOWNLOADED FOR REVIEW WHERE THE REPORTED ISSUE OF THE O2 CONCENTRATION ALARM DURING THE EVENT WAS CONFIRMED. VENTEC OBSERVED THAT ON THE DAY OF THE REPORTED EVENT, THERE WERE SIX (6) O2 CONCENTRATION ALARMS -- FIVE (5) ASSOCIATED WITH TANK PRESSURE AND ONE (1) FOR CONCENTRATION (58%). VENTEC ALSO OBSERVED THAT O2 FLUSH HAD BEEN STARTED MULTIPLE TIMES THROUGHOUT THE DAY. BASED ON THIS INFORMATION, VENTEC DETERMINED THAT THE PATIENT WAS LIKELY RUNNING ON LOWER O2 OUTPUT REGULARLY, AND THEN WHEN RUNNING A FLUSH THE TANK WOULD DROP INTO THE NEGATIVE. SINCE THE UNIT WAS BEING RUN WITH THE LOW TANK, THE CONCENTRATION DROPPED AS A RESULT (BECAUSE IT STARTED PURGING WITH AIR INSTEAD OF O2). FURTHERMORE, VENTEC OBSERVED THAT MEDICAL PERSONNEL HAD SET THE PATIENT CIRCUIT TYPE INCORRECTLY BASED ON THE PATIENT SETTINGS. A PASSIVE PATIENT CIRCUIT WITH O2 SHOULD HAVE BEEN SELECTED FOLLOWED BY A PRE-USE TEST, PRIOR TO USE. VENTEC THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, VENTEC HAS DETERMINED THAT IT'S REASONABLE TO CONCLUDE THAT THE LIKELY ROOT CAUSE OF THE O2 CONCENTRATION ALARM WAS USER ERROR. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER CONDUCTING A RETROSPECTIVE REVIEW OF PRIOR COMPLAINT RECORDS. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT THE VENTILATOR PROVIDED AN O2 CONCENTRATION ALARM DURING PATIENT USE. THE PATIENT ALLEGEDLY DESATURATED TO 80% AND HAD TO BE MANUALLY VENTILATED IN ORDER TO GET BACK TO NORMAL O2 LEVELS. THE PATIENT WAS THEN PLACED ON A BACKUP VOCSN FOR CARE. THE REPORTED ISSUE RESULTED IN THE PATIENT'S O2 LEVELS DECREASING WHICH REQUIRED INTERVENTION BY MEDICAL PERSONNEL TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503133 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01100-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention