BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 966057 · Received December 18, 2007

    Report

    Report Number
    2031642-2007-00228
    Event Type
    Other
    Date Received
    December 18, 2007
    Date of Event
    November 27, 2007
    Report Date
    November 27, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SCREEN WENT BLANK AND THEN SHUT DOWN WHILE IN USE ON APT. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PT, AND THERE WAS NO PT HARM. THE RESPIRONICS SERVICE TECH WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM, HOWEVER, THE VENTILATOR DIAGNOSTIC LOG REVEALED THE BACKUP BATTERY HAD BECOME DEPLETED UPON EXTENDED USE, WHICH WILL RESULT IN THE VENTILATOR ALARMING AND SHUTTING DOWN. FINAL TESTING WAS COMPLETED AND THE UNIT PASSED INSPECTION AND TESTING TO SPECIFICATIONS. WHEN THE VENTILATOR IS EQUIPPED WITH A BACKUP BATTERY AND IT IS IN USE, THE VENTILATOR ALARMS INDICATING THE BACKUP BATTERY IS THE POWER SOURCE FOR VENTILATOR OPERATION. THE USER ALLOWED THE BACKUP BATTERY TO DEPLETE UPON USE, CONTRIBUTING TO THIS EVENT.

    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 UNK YR