BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11864487 · Received May 21, 2021

    Report

    Report Number
    3013095415-2021-00026
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 26, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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. VENTEC FURTHER INVESTIGATED THE REMOVED PCB AND FOUND THAT DIODE, DESIGNATOR D200X, WAS SHORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THE DEVICE TO UNEXPECTEDLY SHUT DOWN WHILE IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761453 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01100-000

    Patients

    Seq Age Sex Outcome Treatment
    1