BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2031858 · Received March 28, 2011

    Report

    Report Number
    2031642-2011-00078
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED TESTING OF THE NURSE CALL ALARM FAILED. THE THIRD PARTY SERVICE AGENCY OR USER HAD REPORTED NO FAILURE OF THE NURSE CALL ALARM DURING USE. FAILURE OF THE NURSE CALL ALARM MAY RESULT IN NO SIGNAL TO THE REMOTE ALARM STATION WHEN THE VENTILATOR ALARMS DURING USE. THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE SERVICE TECHNICIAN INFORMED THE THIRD PARTY SERVICE AGENCY THAT THE MAIN PCB BOARD NEEDED REPLACEMENT TO CORRECT THE FINDING. THE THIRD PARTY SERVICE AGENCY DECLINED SERVICE AND REPORTED THEY WOULD NOTIFY THE MANUFACTURER IF THEY WANTED TO PROCEED WITH THE RECOMMENDED REPAIR. THE SERVICE TECHNICIAN POSTED FAILURE OF THE TEST ON THE DEVICE.

    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