BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2221064 · Received August 23, 2011

    Report

    Report Number
    2031642-2011-00278
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 1, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR PASSED TESTING DURING EVALUATION. THE VENTILATOR'S LOG HISTORY WAS REVIEWED WITH THE CARDIOPULMONARY DIRECTOR WHO NOTED THAT ON THE DAY/TIME OF THE REPORTED PROBLEM THE VENTILATOR'S BACKUP BATTERY HAD DEPLETED 30 MINUTES AFTER THE VENTILATOR HAD BEEN POWERED ON INTO NORMAL VENTILATION MODE OPERATION. IF THE BACKUP BATTERY DEPLETES DURING USE, THE VENTILATOR WILL SHUT DOWN AND AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE. THIS EVENT IS BEING REPORTED AS A USER ERROR. PER THE ESPRIT OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY THE BACKUP BATTERY IT WILL GENERATE A NONRESETABLE, NONSILEANCEABLE 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 NONRESETABLE HIGH PRIORITY ALARM WILL SOUND. WHEN THE BATTERY LOW INDICATOR IS FLASHING RED, OPERATION OF THE VENTILATOR FROM THE BATTERY POWER SHOULD BE DISCONTINUED.

    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