BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1645142 · Received March 30, 2010

    Report

    Report Number
    2031642-2010-00053
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LONGER UNDER WARRANTY FOR SERVICE BY RESPIRONICS; BIOMED PERFORMS SERVICE. RESPIRONICS CALIFORNIA INC. SERVICE TECHNICIAN PROVIDED SERVICE ASSISTANCE TO BIOMED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THE UNIT ALARMED AND WENT VENT INOP AFTER SOME POWER ISSUES AT THE HOSPITAL. THERE WAS NO PATIENT HARM REPORTED. REVIEW OF THE VENTILATOR DIAGNOSTIC CODE HISTORY REVEALED THE VENTILATOR'S BACKUP BATTERY HAD DEPLETED DURING USE PRIOR TO THE VENT INOP OCCURRENCE. THE BIOMEDICAL ENGINEER CHARGED THE BACKUP BATTERY OVERNIGHT AND TESTED IT THE NEXT DAY AND IT FAILED TESTING. THE BIOMEDICAL ENGINEER REPLACED THE BACKUP BATTERY. THIS EVENT IS BEING REPORTED AS A USER ERROR. THE CUSTOMER REPORTED THE HOSPITAL WAS EXPERIENCING POWER ISSUES WHICH, WHEN OCCURRING, WILL OPERATE THE VENTILATOR VIA BACKUP BATTERY POWER UNTIL AC POWER IS RESTORED BY THE USER. THE DIAGNOSTIC LOG SHOWED THE VENTILATOR HAD BEEN OPERATING ON BACKUP BATTERY POWER WHICH THEN DEPLETED DURING EXTENDED USE. PER THE VENTILATOR'S OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY BACKUP BATTERY IT WILL GENERATE A NONRESECTABLE, NON SILENCEABLE ALARM EVERY 60 SECONDS. DURING THIS STATE A YELLOW BATTERY IN USE LED IS LIT. OPERATION WILL CONTINUE IN THIS STATE UNTIL THE BATTERY CAPACITY IS NEARLY EXPENDED. WHEN THE BATTERY HAS ONLY ABOUT 5 MINUTES OF OPERATION LEFT, AN AUDIBLE, NONRESECTABLE HIGH PRIORITY ALARM WILL SOUND AND A RED BATTERY LOW LED WILL FLASH CONTINUOUSLY. 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 VENTILATOR IS PLUGGED INTO A VIABLE AC SUPPLY.

    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