BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2031861 · Received March 28, 2011

    Report

    Report Number
    2031642-2011-00082
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR'S AC POWER CORD SHOWED EVIDENCE OF OVERHEATING AT THE PLUG END. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT, AND THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED NO INTERRUPTION IN THE VENTILATOR'S FUNCTION OR PERFORMANCE. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED VISUAL INSPECTION OF THE AC POWER CORD SHOWED DISCOLORATION OF THE PLUG AND THE NEUTRAL BLADE WAS MISSING. THE SERVICE TECHNICIAN REPLACED THE POWER CORD TO COMPLETE THE REPAIR, AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED. FACTORY ANALYSIS OF THE AC POWER CORD ALSO REVEALED THAT THE BLACK HOT POST AND THE GREEN GROUND POST WERE BOTH BENT, WITH THE REPORTED FINDINGS INDICATIVE OF PRODUCT ABUSE. THE FINDINGS MAY RESULT IN A LOSS OF AC POWER TO THE VENTILATOR DURING OPERATION. IF THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    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