BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 13978724 · Received April 1, 2022

    Report

    Report Number
    3013095415-2022-00424
    Event Type
    Death
    Date Received
    April 1, 2022
    Date of Event
    December 1, 2021
    Report Date
    March 7, 2022
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VENTEC HAS REACHED OUT TO THE USER FACILITY TO REQUEST ADDITIONAL INFORMATION ABOUT THE PATIENT, AS WELL AS OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT. NO RESPONSE HAS BEEN RECEIVED. THE REPORTER, A DISTRIBUTOR, ADVISED VENTEC THAT THE FAMILY OF THE PATIENT WILL NOT RELEASE THE DEVICE FOR EVALUATION AT THIS TIME. VENTEC CONTINUES TO INVESTIGATE THE REPORTED ISSUE. 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 SUBSEQUENTLY RELEASED BY THE PATIENT'S FAMILY AND RETURNED TO VENTEC FOR EVALUATION. THERE HAS BEEN NO ADDITIONAL INFORMATION ABOUT THE PATIENT, OR THE REPORTED EVENT, PROVIDED BY EITHER THE DISTRIBUTOR OR USER FACILITY SINCE THE INITIAL MEDWATCH REPORT WAS SUBMITTED. UPON RECEIPT OF THE DEVICE, VENTEC OBSERVED THAT BOTH OF THE DEVICES INVOLVED IN THE REPORTED ADVERSE EVENT (THIS ONE AND SERIAL NUMBER 115467 WHICH HAD BEEN DOCUMENTED IN MEDWATCH REPORT 3013095415-2022-00425) HAD BEEN RETURNED IN PACKAGING NOT APPROVED BY VENTEC LIFE SYSTEMS. BOTH VOCSN DEVICES WERE SENT IN THE SAME, OVERSIZED, SHIPPING BOX ALONG WITH THEIR ACCESSORIES. THE SHIPPING BOX DID NOT CONTAIN ANY TYPE OF PACKING MATERIALS (I.E. PACKING PEANUTS OR FOAM) TO PREVENT THE DEVICES OR ACCESSORIES FROM SHIFTING OR MOVING AROUND DURING TRANSPORT. THE VOCSN CLINICAL AND TECHNICAL MANUAL ADVISES THE FOLLOWING [P.172]: "SHIPPING CONSIDERATIONS. TO ENSURE THE DEVICE IS NOT DAMAGED DURING SHIPMENT, AND THAT THE SHIPMENT MEETS ALL APPLICABLE REGULATIONS, ALWAYS USE PACKAGING APPROVED BY VENTEC LIFE SYSTEMS WHEN SHIPPING VOCSN. CONTACT VENTEC LIFE SYSTEMS WITH QUESTIONS, AND TO OBTAIN PACKAGING MATERIALS." VENTEC OBSERVED THAT THIS DEVICE'S LCD TOUCHSCREEN DISPLAY WAS CRACKED AND UNRESPONSIVE TO TOUCHES, ALONG WITH NUMEROUS OTHER SCUFFS AND SCRATCHES. THERE WERE NO REPORTS OF ANY LCD TOUCHSCREEN ISSUES BY THE CUSTOMER. IT IS NOT KNOWN HOW THE LCD BECAME CRACKED; HOWEVER, BASED ON THE EVIDENCE OF HOW THE DEVICE WAS PACKAGED AND RECEIVED, IT IS REASONABLE TO CONCLUDE THAT THE LCD BECAME CRACKED AND UNRESPONSIVE DURING SHIPMENT. VENTEC REPLACED THE FRONT CASE ASSEMBLY (WHICH INCLUDES THE LCD TOUCHSCREEN) IN ORDER TO PROCEED WITH TESTING. VENTEC ALSO OBSERVED THAT THE DEVICE COULD ONLY POWER ON IF EXTERNAL BATTERIES WERE INSTALLED. WHEN EXTERNAL BATTERIES OR EXTERNAL AC POWER WERE APPLIED, THE DEVICE POWERED ON AUTOMATICALLY. INTERNAL BATTERY ICON SHOWS RED '?', INDICATING IT IS NOT BEING RECOGNIZED. THE REPORTED ADVERSE EVENT OCCURRED DURING THE MONTH OF DECEMBER, 2021, AND THE DEVICE WAS NOT RECEIVED BY VENTEC UNTIL OCTOBER 31ST, 2022. BASED ON THE EVIDENCE AVAILABLE, IT DOES NOT APPEAR THAT THE DEVICE WAS STORED APPROPRIATELY FROM THE TIME OF THE EVENT UNTIL THE DEVICE WAS RETURNED TO VENTEC FOR EVALUATION. THE VOCSN CLINICAL AND TECHNICAL MANUAL ADVISES THE FOLLOWING [P.169] "BATTERY STORAGE MODE. VOCSN IS SHIPPED IN BATTERY STORAGE MODE TO PRESERVE THE CHARGE OF ITS THREE BATTERIES. WITH SOFTWARE VERSIONS 4.11R AND LATER, USERS CAN SELECT THE ACTIVATE BATTERY STORAGE MODE CONTROL IN THE DEVICE SETTINGS AND PLACE THE FULLY CHARGED INTERNAL BATTERY AND BOTH REMOVABLE, RECHARGEABLE BATTERIES BACK INTO THIS POWER-SAVING STORAGE MODE. THIS ALLOWS VOCSN TO REMAIN IN STORAGE FOR 12 MONTHS AT A TIME BETWEEN RECHARGING THE BATTERIES. IMPORTANT NOTE: IF BATTERY STORAGE MODE IS NOT USED, ALL THREE VOCSN BATTERIES SHOULD BE FULLY CHARGED EVERY 30 DAYS." THERE IS NO EVIDENCE THESE STEPS WERE TAKEN IN ORDER TO PRESERVE THE DEVICE'S INTERNAL AND EXTERNAL BATTERY LIFE. ONCE POWER WAS PROPERLY APPLIED TO THE VOCSN, VENTEC WAS ABLE TO DOWNLOAD THE ELECTRONIC RECORDS FROM THE EVENT FOR ANALYSIS. NO ABNORMALITIES WERE OBSERVED. PROPER DEVICE OPERATION WAS CONFIRMED. VENTEC THEN COMPLETED OTHER, UNRELATED, REPAIRS. PROPER DEVICE OPERATION WAS AGAIN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING PRIOR TO THE DEVICE BEING RETURNED TO THE DISTRIBUTOR. THE CAUSE OF THE REPORTED ADVERSE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A DISTRIBUTOR CONTACTED VENTEC TO REPORT THAT A PATIENT WAS ON A VOCSN VENTILATOR WHEN THEY DIED. NO FURTHER INFORMATION ABOUT THE PATIENT OR THE EVENT WAS PROVIDED. VENTEC WAS ADVISED THAT THE EVENT OCCURRED SOMETIME IN (B)(6) OF 2021. DATE OF DEATH AND DATE OF EVENT WILL REFLECT (B)(6) 2021 UNTIL THE ACTUAL DATE CAN BE CONFIRMED. ADDITIONALLY, THERE WERE REPORTEDLY TWO DEVICES INVOLVED IN THE EVENT. THE OTHER VOCSN DEVICE FROM THIS EVENT (SERIAL NUMBER (B)(4)) IS DOCUMENTED IN MEDWATCH REPORT 3013095415-2022-00425.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486770 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death