BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1896130 · Received November 10, 2010

    Report

    Report Number
    2031642-2010-00309
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FUSE.

    Description of Event or Problem · 1

    THE CUSTOMER HAD PURCHASED THE VENTILATOR FROM A RENTAL/SALES COMPANY. WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN OBSERVED A FUSE IN THE POWER SUPPLY WAS NOT FULLY SEATED IN THE FUSE CLIP. THE OPEN FUSE MAY CAUSE A LOSS OF VALVE OPERATION IN THE VENTILATOR AND GO VENT INOP IF IT WERE TO OCCUR DURING USE. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE CUSTOMER DID NOT REPORT A VENT INOP OCCURRENCE TO THE MANUFACTURER PREVIOUS TO SERVICE OR AT THE TIME OF ITS OCCURRENCE. THERE WAS NO REPORTED PATIENT HARM. THE SERVICE TECHNICIAN ADJUSTED THE FUSE CLIP AND RESEATED THE CLIP TO ADDRESS THE FINDING. 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