BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1053646 · Received May 27, 2008

    Report

    Report Number
    2031642-2008-00130
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR POWER CORD WAS HOT TO THE TOUCH. THE VENTILATOR WAS NOT IN USE ON A PT, THEREFORE, THERE WAS NO PT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR FUNCTIONED TO OPERATING SPECIFICATIONS, AND THERE WAS NO FUNCTIONAL ISSUE WITH THE POWER CORD. THE SERVICE TECHNICIAN REPLACED THE POWER CORD. EXTENDED SELF TESTING (EST) WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECS. THE POWER CORD WAS RETURNED TO THE FACTORY FOR FAILURE ANALYSIS. VISUAL INSPECTION OF THE POWER CORD REVEALED DISCOLORATION IN THE PLUG. TESTING REVEALED A PARTIAL OPEN AT THE INTERNAL POST CONNECTOR WHERE THE HOT LEAD IS ATTACHED. A POWER CORD MALFUNCTION DURING USE COULD CAUSE A LOSS OF AC POWER TO THE VENTILATOR.

    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 NA