BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 1162220 · Received September 16, 2008

    Report

    Report Number
    2031642-2008-00198
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT HAD AN ODOR OF OVERHEATING. THE VENTILATOR WAS IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. DURING INITIAL EVALUATION THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED ODOR. DURING INTERNAL INSPECTION OF THE VENTILATOR THE SERVICE TECHNICIAN REPORTED FINDING THE FAN ON THE POWER SUPPLY NOT FUNCTIONING, AND A COMPONENT ON THE POWER SUPPLY DAMAGED. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO CORRECT THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTMS PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK