BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3211701 · Received July 8, 2013

    Report

    Report Number
    2031642-2013-00325
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 25, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WOULD NOT POWER ON VIA AC POWER. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE TECHNICIAN REPORTED THE DEVICE WOULD NOT POWER ON VIA AC POWER UNTIL THE BACKUP BATTERY WAS DISCONNECTED. BASED ON THE REPORTED FINDING, IF DURING NORMAL VENTILATION MODE AC POWER WAS LOST, IT MAY RESULT IN A SHUTDOWN OF THE DEVICE. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT PCB BOARD TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311793 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1