BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS VIVO 50 FW2.00

    MDR report key: 4232302 · Received June 19, 2014

    Report

    Report Number
    9617566-2014-00002
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    PMA / PMN Number
    123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(4) LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE LOG FILE ANALYSIS CONFIRMED ONE INSTANCE OF ERROR 21 OCCURRED ON (B)(6) 2014. ERROR 21 SIGNALS A COMMUNICATION FAILURE BETWEEN THE DEVICE'S MAIN PROCESSOR AND ITS SENSOR BLOCK. THE FAILURE HAD OCCURRED DURING TREATMENT RUNNING ON INTERNAL BATTERY AT 13:49 AND THE DEVICE IMMEDIATELY ENTERED THE ACTIVE FAILURE STATE. THE DEVICE WAS MANUALLY RESTARTED APPROX 3 MINUTES AFTER THE ERROR HAD TRIGGERED THIS FAIL-SAFE SHUT-DOWN, THIS INDICATING AN INTERMITTENT ERROR. NO OTHER ALARMS WERE TRIGGERED IMMEDIATELY PRIOR TO THE SHUT-DOWN. DURING THE ALARM PERIOD (FUNCTION FAILURE ACTIVE), THE VIVO 50 IS DESIGNED TO GIVE AN ALARM SIGNAL BOTH VISUALLY AND AUDIBLE. THERE ARE 2 BEEPERS FOR REDUNDANCY REASONS CONTROLLED BY THE 2 INDEPENDENT PROCESSORS, WHICH ARE MONITORING EACH OTHER AND A NUMBER OF SENSORS. IN ADDITION, BOTH BEEPERS AND THEIR 2 SEPARATE BACK-UP BATTERIES ARE TESTED BEFORE TREATMENT START. THE ALARM WILL BE ACTIVE FOR 10 MINS OR UNTIL THE POWER BUTTON IS PRESSED. AN IN-DEPTH LOG FILE ANALYSIS REVEALED THE REASON FOR THE ERROR TO BE TRIGGERED WAS BECAUSE COMMUNICATION BETWEEN MAIN PROCESSOR AND THE SENSORS' ADC (ANALOG-TO-DIGITAL CONVERTER) WAS DISTURBED. THE EXACT TRUE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE FAULT COULD NOT BE REPRODUCED, HOWEVER, AN ESD INDUCED EVENT BEYOND SPECIFIED LIMITS (PER EN 60601-1-2 AND ASTM F1246-91) CANNOT BE RULED OUT. THE DEVICE WAS WORKED AS INTENDED AND AS DESIGNED WHEN A COMMUNICATION ERROR IS DETECTED. THE ERROR, WHICH TRIGGERED A FAIL-SAFE SHUT-DOWN (ERROR CODE #21), WAS INTERMITTENT AND THE DEVICE COULD BE RESTARTED. THE DEVICE'S LOG FILES CONFIRM THAT THE TREATMENT SESSION ON (B)(6) HAS ENDED NORMALLY IN AN ACTIVE STATE OF FUNCTIONAL FAILURE. ANALYSIS OF THE DEVICE HARDWARE DID NOT SHOW ANY EVIDENCE THAT THE DEVICE STOPPED WITHOUT ALARM. IN FACT, BOTH THE LOG ENTRIES AND THE WORKING HARDWARE ARE INDICATING THAT THE ALARM WAS INDEED WORKING, BOTH AUDIBLY AND VISUALLY, WHEN THE FUNCTIONAL FAILURE WITH ERROR CODE #21 OCCURRED. THE ALARM WAS CLEARED MANUALLY VIA THE POWER ON BUTTON AFTER APPROX 3 MINUTES, ACCORDING TO THE LOG FILES. THE ROOT CAUSE IS ASSUMED TO BE EXPOSURE TO AN EMC OR ESD EVENT BEYOND DESIGN SPEC LIMITS (ACCORDING TO EN 60601-1-2 AND ASTM E1246-91), RELEVANT FOR FIRMWARE VERSION FW 2.00 OF THE REPORTED DEVICE, UPGRADING THE VIVO (B)(4) TO A FIRMWARE LATER THAN FW 2.00 WILL PROVIDE BETTER IMMUNITY AGAINST EMC/ESD DISTURBANCES, DUE TO FURTHER ENHANCEMENTS ABOVE REQUIREMENTS. A NEW FIRMWARE WAS MADE PUBLICLY AVAILABLE ON 11/18/2013, AND HAS BEEN ACTIVELY PROMOTED AS A RECOMMENDED UPGRADE. ALL VIVO (B)(4) DEVICES SOLD TO US CUSTOMERS HAVE BEEN CONFIGURED AT THE FACTORY WITH A FIRMWARE LATER THAN (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S DESCRIPTION: "DURING PLUG-IN OF THE HOME CARE VENTILATOR UNIT TO THE 220V POWER, A COMPLETE BREAKDOWN OF THE DEVICE WITHOUT AN ALARM DID OCCUR. DUE TO THE NEUROLOGICAL DISEASE OF THE PT WITH STRONG REDUCED FUNCTIONALITY OF THE ARM AND BREATHING MUSCULATURE, A STOP OF BREATHING WOULD HAVE BEEN THE CONSEQUENCE WITHOUT EXTERNAL HELP. THE HYPOXIA COULD BE AVOIDED BY QUICK AND COMPETENT ACTIONS OF THE PRESENT CAREGIVER". THE DEVICE WAS RETURNED TO SWEDEN FOR INVESTIGATION ON (B)(4), WITH FIRMWARE VERSION 2.0 AND A TOTAL OPERATING TIME OF ABOUT 4000 HOURS. THE INVESTIGATION COMPRISED A DETAILED ANALYSIS OF THE DEVICE LOG FILES, A VISUAL INSPECTION OF THE HARDWARE, A PROVOKING TEST, AS WELL AS A FULL PRODUCTION TEST IN THE MFG LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359565 BREAS VIVO 50 FW2.00 HOMECARE VENTILATOR NOU BREAS MEDICAL AB VIVO 50 FW 2.00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other