BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT

    MDR report key: 612456 · Received May 31, 2005

    Report

    Report Number
    2031642-2005-00079
    Event Type
    Other
    Date Received
    May 31, 2005
    Date of Event
    April 27, 2005
    Report Date
    April 27, 2005
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN AND ALARMED WHEN THE FACILITY LOST POWER. THE CUSTOMER REPORTED THE BACKUP BATTERY WAS NOT WORKING. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PT, AND THERE WAS NO HARM. THE RESPIRONICS SERVICE TECHNICIAN REPORTED THE DIAGNOSTIC LOG SHOWED THE BACKUP BATTERY DEPLETED SEVERAL TIMES WHILE IN USE. THE SERVICE TECHNICIAN PERFORMED TESTING OF THE BACKUP BATTERY AND ALL TESTS PASSED. THE SERVICE TECHNICIAN REPORTED THE MAINS LEAD WAS GOING OFF AND ON AND REPORTED FINDING THE POWER SUPPLY FAN DISCONNECTED. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AS A PRECAUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN