BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 2151761 · Received July 6, 2011

    Report

    Report Number
    2031642-2011-00216
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 9, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND POWERED DOWN WHILE IT WAS RUNNING ON BACKUP BATTERY AND HAD A DEPLETED BATTERY. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE AND THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN VERIFIED THE BACKUP BATTERY WAS DEPLETED AND WASN'T BEING CHARGED. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG VERIFIED THE DEVICE WAS OPERATING ON BACKUP BATTERY POWER AND THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED AS A RESULT OF USE, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AND BACKUP BATTERY TO COMPLETE THE SERVICE. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. PER THE VENTILATOR'S OPERATOR'S MANUAL, WHEN THE VENTILATOR IS POWERED BY BACKUP BATTERY IT WILL GENERATE A NONRESECTABLE, 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 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 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1