BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 17931369 · Received October 13, 2023

    Report

    Report Number
    3013095415-2023-00628
    Event Type
    Death
    Date Received
    October 13, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 20, 2023
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC AND ITS SYSTEM LOGS DOWNLOADED FOR ANALYSIS. NO DISCREPANCIES WERE OBSERVED. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. VENTEC WAS UNABLE TO CONFIRM ANY ISSUES WITH THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 002 ¿ SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT STATED: PRT-00490-001. SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: VOCSN, ENGLISH. SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT STATED: (B)(4). SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(4).

    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.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO VENTEC: "HELLO, I HAVE A VOCSN THAT I WOULD LIKE TO SEND IN. WE DON'T SUSPECT ANYTHING IS WRONG WITH THE VENT BUT A PATIENT DIED WHILE ON IT. WE JUST WANT TO HAVE A RECORD OF IT BEING TESTED FROM THE MANUFACTURER. PATIENT WAS ON VENTILATOR AT TIME OF DEATH OXIMETER WAS IN THE HOME BUT CAN'T VERIFY IF PATIENT WAS USING AT TIME OF DEATH. DOWNLOAD WAS DONE ON VENTILATOR AFTER WE RECEIVED BACK FROM PATIENTS CARE GIVER. THE PATIENT HAD LUNG ISSUES AND WAS TRACH DEPENDENT. WE WERE TOLD BY THE MOTHER THAT THE PHYSICIAN STATED "NATURAL CAUSES". SADLY, THE CHILD HAD BEEN SICKLY HIS ENTIRE LIFE. WE HAD NO INDICATION FROM THE MOTHER THAT SHE SUSPECTED ANY PROBLEM WHATSOEVER WITH THE VOCSN. SHE DID HAVE A SECOND VOCSN FOR EMERGENCY PURPOSES IN THE HOME." FURTHERMORE, VENTEC RECEIVED A COPY OF THE VOLUNTARY MEDWATCH SUBMITTED BY THE INITIAL REPORTER (REPORT # MW5146101). WHILE THE PATIENT WAS ON THE DEVICE AT THE TIME OF DEATH, THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION, NOR WAS IT ALLEGED THAT THE DEVICE USE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631547 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC VOCSN, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Death