BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2072214 · Received April 28, 2011

    Report

    Report Number
    2031642-2011-00135
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 1, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE REQUIRED; UNIT OUT OF WARRANTY. USER ERROR; CORRECTIVE ACTION TAKEN BY CUSTOMER. NO SERVICE REQUIRD; UNIT OUT OF WARRANTY.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL ENGINEER REPORTED THE VENTILATOR AC POWER CORD WAS NOT PLUGGED INTO THE AC OUTLET. THE BIOMEDICAL ENGINEER REPORTED THE TECHNICIAN HAD PLUGGED THE HUMIDIFIER INTO THE AC OUTLET INSTEAD OF THE VENTILATOR. AS A RESULT, THE VENTILATOR WAS BEING POWERED VIA THE BACKUP BATTERY. THE VENTILATOR OPERATED ON BACKUP BATTERY UNTIL THE BACKUP BATTERY DEPLETED, AND THE VENTILATOR THEN SHUT DOWN AND ALARMED. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG VERIFIED THE DEVICE WAS OPERATING ON BACKUP BATTERY POWER AND THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. THERE WAS NO PATIENT HARM REPORTED, AND THE TECHNICIAN WAS AT THE BEDSIDE AND PLACED THE PATIENT ON ANOTHER VENTILATOR. THIS EVENT IS BEING REPORTED AS A USER ERROR. PER THE VENTILATOR'S OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY 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