BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 1051336 · Received May 21, 2008

    Report

    Report Number
    2031642-2008-00114
    Event Type
    Other
    Date Received
    May 21, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    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 BEGAN ALARMING 'LOW BATTERY' AND THEN SHUT DOWN WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR'S DIAGNOSTIC LOG SHOWED THE DEVICE HAD BEEN RUNNING ON BACKUP BATTERY POWER WHICH BECAME DEPLETED DURING EXTENDED USE. THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED CAUSING THE VENTILATOR TO SHUT DOWN AND ALARM AS SPECIFIED. APPLICABLE TESTING WAS COMPLETED AND ALL TESTS PASSED PER SPECIFICATIONS. THERE WAS NO MALFUNCTION OF THE DEVICE OR BACKUP BATTERY. THIS EVENT IS BEING REPORTED AS A USER ERROR. PER THE ESPIRIT OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY BACKUP BATTERY IT WILL GENERATE A NON-RESETTABLE, NONSILENCEABLE ALARM EVERY 60 SECONDS. DURING THIS STATE A BATTERY IN USE YELLOW LED IS LIT. OPERATION WILL CONTINUE UNTIL THE BATTERY HAS 5 MINUTES OF OPERATION LEFT. A RED BATTERY LOW LED WILL FLASH AND A NON-RESETTABLE HIGH PRIORITY ALARM WILL SOUND. WHEN THE BATTERY LOW INDICATOR IS FLASHING RED, OPERATION OF THE VENTILATOR FROM THE BATTERY POWER SHOULD BE DISCONTINUED. THE BACKUP BATTERY WILL CHARGE WHEN THE ESPIRIT IS PLUGGED INTO A VIABLE AC SUPPLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK