BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11697925 · Received April 20, 2021

    Report

    Report Number
    3013095415-2021-00021
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    November 19, 2019
    Report Date
    April 20, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Removal / Correction Number
    3013095415-4/12/2021-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H9: AFTER ADDITIONAL ANALYSIS BY VENTEC, IT HAS BEEN DETERMINED THAT THERE IS A POTENTIAL RISK TO HEALTH ASSOCIATED WITH BLOWER CIRCUIT FAILURES RESULTING IN UNEXPECTED SHUT DOWNS AND/OR LOSS OF VENTILATION. AS A RESULT OF THIS INVESTIGATION, VENTEC HAS INITIATED A FIELD CORRECTIVE ACTION (REFERENCE CORRECTIONS AND REMOVALS NUMBER 3013095415-4/12/2021-001-R).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR AN INVESTIGATION. THE REPORTED EVENT OF UNEXPECTED SHUTDOWN WAS CONFIRMED. THE INVESTIGATION DETERMINED AN ELECTRICAL COMPONENT FAILED ON THE MOTHERBOARD PRINTED CIRCUIT BOARD (PCB), WHICH CAUSED THE UNEXPECTED SHUTDOWN. AFTER REPLACING THE PCB, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE UNEXPECTEDLY SHUT DOWN WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589347 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1