BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1801953 · Received August 16, 2010

    Report

    Report Number
    2031642-2010-00230
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    April 29, 2010
    Report Date
    April 29, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE VENTILATOR ALARMED, THE FACILITY REMOTE ALARM DID NOT ALARM. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB BOARD TO CORRECT THE PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1