BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3830072 · Received May 23, 2014

    Report

    Report Number
    2031642-2014-00387
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    December 6, 2024
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING DUE TO A VENT INOP. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A VENT INOP OCCURRENCE DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM. THE SERVICE ENGINEER REPLACED THE DATA ACQUISITION PCB BOARD TO ADDRESS THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED TO OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308759 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown