BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT

    MDR report key: 612462 · Received May 31, 2005

    Report

    Report Number
    2031642-2005-00070
    Event Type
    Other
    Date Received
    May 31, 2005
    Date of Event
    April 29, 2005
    Report Date
    April 29, 2005
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SHUT DOWN WHILE IN USE ON A PT. THE CUSTOMER REPORTED THE VENTILATOR'S BACKUP WAS NOT CONNECTED TO THE VENTILATOR WHEN THE HOSP PERFORMED A GENERATOR CHECK. THERE WAS NO PT HARM REPORTED. THE CUSTOMER TOLD THE RESPIRONICS SERVICE TECHNICIAN THAT THE RESPIRATORY DEPARTMENT HAD NOT CONNECTED THE BACKUP BATTERY DUE TO THEIR INTERPRETATION OF INSTRUCTIONS IN BACKUP BATTERY OPTION INSERT IN THE ESPIRT OPERATORS MANUAL. THE INSTRUCTIONS STATE "DO NOT CONNECT THE DC POWER CORD FROM THE BACKUP BATTERY WHILE ESPIRT IS FUNCTIONING AS A VENTILATOR. ALWAYS TURN THE POWER ON/OFF SWITCH TO OFF." THE SERVICE TECHNICIAN REPORTED THE RESPIRATORY DEPARTMENT HAS INTERPRETED THIS STATEMENT TO MEAN THAT THE BATTERY SHOULD NOT BE CONNECTED WHILE THE ESPIRT IS IN USE. HOSP BIOMED TOLD THE RESPIRATORY DEPARTMENT THAT THEIR INTERPRETATION WAS INCORRECT. THE RESPIRONICS SERVICE TECHNICIAN INSTRUCTED THE RESPIRATORY SUPERVISOR AND STAFF THAT THE BACKUP BATTERY MUST STAY CONNECTED WHEN THE ESPRIT IS IN USE.

    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 NA