BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1113314 · Received August 12, 2008

    Report

    Report Number
    2023050-2008-00058
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - ANALYSIS: THE VENT RAN ON AC SUPPLY WITHOUT GENERATING ERROR CODES. UNPLUGGED AC POWER CORD, FOUND EXT BATTERY INDICATOR DISPLAYED AT UPPER RIGHT WINDOW AND THE FRONT PANEL INTERNAL BATTERY LED OFF. THE VENT SHOULD HAVE DISPLAYED INTERNAL BATTERY. UNIT WAS VENTILATING FOR SEVERAL MINUTES AND THEN IT DISPLAYED "INCOMPATIBLE DISPLAY BOARD SOFTWARE" AND "NO COMMUNICATION" IN THE MESSAGE CENTER. FINALLY, THE VENT STOPPED VENTILATING WITH ALL LEDS ON FRONT PANEL FROZEN. MEASURED INTERNAL BATTERY AND FOUND IT TO BE = 7.59V (CRITICALLY DEPLETED.) VISUALLY INSPECTED CONNECTIVITY OF ALL CABLES AND FOUND CBL2101A PIN #2 WAS LOOSE AND STICKING OUT OF THE CONNECTOR HOUSING. ON SCHEMATIC SCH2101A, PIN #2 IS THE VOLTAGE INTERNAL BATTERY SIGNAL (VBAT INT1). REINSERTED PIN #2 (CBL2101A) AND THE DISPLAY BANNER SHOWED INTERNAL BATTERY. THE FRONT PANEL INTERNAL BATTERY LED WAS ALSO LIT. A REVIEW OF THE EVENT HISTORY LOG FOR INCIDENT DATE IN 2008 SHOWS THAT THE UNIT WAS RUNNING ON INTERNAL BATTERY POWER, NOT AC POWER. FURTHER EVALUATION SHOWS THAT IF THE VENT IS RUNNING ON INTERNAL BATTERY POWER AND CBL2101A PIN #2 IS DETACHED, THE VENT WOULD DRAIN THE BATTERY TO A CRITICALLY LOW VOLTAGE AS MEASURED ABOVE. WITH CBL2101A PIN #2 RECONNECTED, THE VENT SHOWED LOW BATTERY, POWER FAILS, AND DEVICE ALARM PRIOR TO SHUT DOWN SAFELY. THE VENT WAS CYCLED BETWEEN AC POWER AND INTERNAL BATTERY POWER NUMEROUS TIMES, NO OTHER PROBLEMS WERE OBSERVED. CONCLUSION: PIN #2 (CBL2101A) WAS LOOSE AND PARTIALLY HANGING OUT OF THE CONNECTOR HOUSING. THIS CONDITION PREVENTED THE VENTILATOR FROM PROPERLY NOTIFYING THE USER THAT THE BATTERY WAS LOW, SOUNDING THE ALARM AND SHUTTING DOWN SAFELY. RECOMMEND T/S REPLACE, INTERNAL BATTERY BAT1800P, UPGRADE SOFTWARE AND PERFORM CALIBRATIONS. PRODUCTION AND QC WERE NOTIFIED OF THIS REPORT FOR FURTHER EVALUATIONS. PRODUCTION TO PERFORM 100% INSPECTION OF INVENTORY CABLES.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR SHUT DOWN WITHOUT TURNING OFF THE SWITCH. IT WAS RUNNING ON A PATIENT. THE VENTILATOR GAVE AN ALARM; HOWEVER, NO EVENT HISTORY OF THIS INCIDENT WAS IN THE HISTORY LOG. LATER, ADDITIONAL INFORMATION WAS RECEIVED BY THE REPORTER THAT THE RESPIRATORY THERAPIST WAS OUTSIDE THIS PATIENT'S ROOM ALONG WITH THE DIRECTOR OF THE HOSPITAL. THEY HEARD THE VENTILATOR ALARM, STEPPED IN THE ROOM AND SAW THE VENTILATOR WITH A BLANK SCREEN BUT WITH AN AUDIBLE ALARM. THE ISSUE (VENTILATOR SHUT DOWN) WAS FOUND AFTER A CONSTANT VENTILATOR ALARM OF APPROXIMATELY 20 SECONDS, AND THEY FOUND THE VENTILATOR WITH A BLANK SCREEN, AND CONTINUOUS ALARM/ DEVICE ALERT. THE DIRECTOR THEN SWITCHED THE VENTILATOR OFF AND BACK ON, AND THE POWER CAME RIGHT BACK UP. THE PATIENT WAS AMBU BAGGED. HE/SHE WAS NOT TOTALLY VENTILATOR DEPENDENT. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK