BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 1903988 · Received November 20, 2010

    Report

    Report Number
    2031642-2010-00307
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 25, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN AND ALARMED WHILE IN USE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT. REVIEW OF THE VENTILATORS DIAGNOSTIC HISTORY NOTED A +5V AND/OR 12/24 VOLT POWER FAILURE AND RESTART DURING OPERATION. THE HOSPITAL BIOMEDICAL TECHNICIAN ALSO REPORTED A VENT INOP OCCURRENCE HOWEVER THE DIAGNOSTIC LOG REVEALED NO VENT INOP OCCURRENCE TO VERIFY THAT REPORT. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1