BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2032979 · Received March 29, 2011

    Report

    Report Number
    2031642-2011-00107
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULDN'T POWER ON INTO VENTILATION. THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT AND MOTOR CONTROLLER PCB BOARDS TO COMPLETE THE REPAIR. FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS. FACTORY ANALYSIS OF THE RETURNED POWER MANAGEMENT PCB BOARD REVEALED A LOSS OF 12 VOLTS DURING TESTING. IF THE NOTED FAILURE WERE TO OCCUR DURING OPERATION, A VENT INOPERATIVE CONDITION COULD OCCUR. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. IF IN USE, THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1