BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2160447 · Received July 13, 2011

    Report

    Report Number
    2031642-2011-00223
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MANUFACTURER'S SERVICE TECHNICIAN REPORTED VISUAL INSPECTION OF THE AC POWER CORD SHOWED PHYSICAL DAMAGE AND WAS TARNISHED WITH ONE PRONG MISSING. THE SERVICE TECHNICIAN REPLACED THE POWER CORD TO COMPLETE THE REPAIR. FACTORY ANALYSIS OF THE AC POWER CORD REVEALED THE PHYSICAL DAMAGE NOTED WAS 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