BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 1940936 · Received December 29, 2010

    Report

    Report Number
    2031642-2010-00343
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED AND RESTARTED 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 RESTART OCCURRENCE. THE SERVICE TECHNICIAN REPLACED THE CPU BOARD TO ADDRESS THE FINDINGS. EXTENDED SELF 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