BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS VIVO 50

    MDR report key: 14883108 · Received July 1, 2022

    Report

    Report Number
    9617566-2022-00005
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822150005
    PMA / PMN Number
    K123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CSSE-35256. INVESTIGATION REPORT VIVO 50 L510460 - ERROR 34 TERMINATED TREATMENT UNDER ALARM. BACKGROUND: ON JUNE 22ND, 2022, BREAS MEDICAL GMBH RECEIVED INFORMATION THAT VIVO 50 S/N: (B)(4) HAD BEEN INVOLVED IN AN INCIDENT IN GERMANY. FAULT DESCRIPTION PER THE REPORTER "ACCORDING TO THE RESPIRATORY THERAPIST THE DEVICE BROKE DOWN. ALARM SOUNDED AND AN INTERNAL FUNCTION FAILURE 34 WAS DISPLAYED. SHORTLY AFTER THE VENTILATOR FAILED."THE PATIENT INVOLVED WAS NOT INJURED DURING THE INCIDENT. THE DEVICE L510460 WAS SOLD ON JANUARY 12TH, 2015 AND PASSED FINAL TEST AT THE FACTORY ON DECEMBER 19TH, 2014. INVESTIGATION: THE DEVICE WAS SENT TO BREAS MEDICAL GMBH AND ARRIVED 28TH OF JUNE 2022. ON THE NEXT DAY, BREAS MEDICAL GMBH STARTED THE EXAMINATION OF THE DEVICE. GENERAL INSPECTION SHOWED THAT THE DEVICE IS IN GOOD SHAPE. IT WAS RUNNING FOR 11745 OP. HOURS AND HAS FIRMWARE 2.16 LOADED. THE DEVICE WAS STARTED, A PRE-USE TEST WAS CARRIED OUT SUCCESSFULLY AND A TEST RUN WAS DONE ON A TEST LUNG USING THE PATIENT´S SETTINGS. THE POWER FAIL ALARM WAS CHECKED, IT WORKED AS INTENDED AND THE DEVICE GAVE AUDIBLE, WITH LEVEL FOR 85DB ±5DB THAT CANNOT BE CHANGED OR TURNED OFF, AND VISIBLE ALARMS. THE LOG FILES WERE DOWNLOADED AND EXAMINED WITH THE PC SOFTWARE VERSION 3.3.1.4. THE LOG FILES COULD ESTABLISH THAT TREATMENT WAS STARTED ON 14TH, JUNE 2022 ON MAINS POWER AT 12:51:19. ONE HOUR AND 12 MINUTES LATER C AT 14:03:03. THE DEVICE WAS RESTARTED BY DIS- AND RECONNECTING MAINS POWER AND STARTING TREATMENT AT 14:11:49. ERROR 34 REOCCURRED IMMEDIATELY AND PREVENTED A RESTART OF THE THERAPY. AT 14:17:58 A RESTART WAS TRIED AGAIN, PERFORMING A PRE-USE TEST THAT FAILED AND ERROR 34 OCCURRED AGAIN. THE DEVICE WAS SWITCHED OFF AT 14:22:36. CAUSE FAULT TRACING OF THE DEVICE COULD NOT ESTABLISH A FAILURE DURING A BENCH TEST. THE VOLTAGE ON TEST POINT 52 (5 V ±0.25V) WAS CHECKED AGAINST GROUND (TP 65) AS RECOMMENDED BY THE SERVICE MANUAL AND FOUND TO BE FAULTLESS AT 4,95 VOLTS.A DAMAGE OF TWO BLOWER CABLES COULD BE IDENTIFIED DURING HARDWARE INSPECTION. THE ORANGE AND THE BLACK CABLE HAVE BEEN JAMMED BETWEEN THE EDGE OF THE HOUSING OF THE INTERNAL BATTERY BOX AND THE SHIELDING OF THE MAIN PROCESSOR OF THE CPU BOARD AND CAUSED A SHORTCUT ON THE SENSOR CABLE OF THE INTERNAL TEMPERATURE SENSOR OF THE BLOWER. BURN MARKS ON THE EDGE OF THE SHIELDING COULD ALSO BE FOUND. THE INNER CONDUCTORS HAVE ALMOST COMPLETELY BEEN CUT AND CAUSED THE DEVICE TO ALARM (ERROR 43 - THE BLOWER DOES NOT FUNCTION PROPERLY) AFTER INVESTIGATION AND REASSEMBLY AT BREAS MEDICAL GMBH.DUE TO THE DEVICE BEING MORE THAN 7 YEARS OLD AND THE PROVIDER LÖWENSTEIN HAVING PERFORMED MAINTENANCE LATEST IN DECEMBER 2021 ACCORDING TO THE LABELS FOUND IT IS POSSIBLE THAT THE DAMAGED WAS CAUSED BY A TECHNICIAN WHEN PERFORMING MAINTENANCE. NOTE: THE BLOWER IS STILL THE ORIGINAL ONE FROM 2014.THE BLOWER CABLES WERE RECONNECTED PROVISIONAL AND A PRE-USE TEST AND COMPLETE FUNCTION TEST INCLUDING CALIBRATION WAS PERFORMED WITH NO FAILURE. THE CUSTOMER WILL RECEIVE A COST ESTIMATE FOR THE REPLACEMENT OF THE BLOWER AND THE CPU BOARD. CONCLUSION AND ACTIONS REVIEW OF THE DEVICE LOG FILES CONFIRMS THAT A FUNCTION FAILURE 34 (BLOWER TEMPERATURE IS BELOW -30°C) OCCURRED AND TERMINATED ACTIVE TREATMENT. AUDIBLE AND VISUAL ALARMS WERE CHECKED AND FOUND TO WORK AS INTENDED. THERE WAS NO PATIENT INJURY. FAULT TRACING OF THE DEVICE COULD ESTABLISH A HARDWARE FAILURE IN FORM OF DAMAGE OF TWO BLOWER CABLES. THE ORANGE AND THE BLACK CABLE HAVE BEEN JAMMED BETWEEN THE EDGE OF THE HOUSING OF THE INTERNAL BATTERY BOX AND THE SHIELDING OF THE MAIN PROCESSOR OF THE CPU BOARD AND CAUSED A SHORTCUT ON THE SENSOR CABLE OF THE INTERNAL TEMPERATURE SENSOR OF THE BLOWER. BURN MARKS ON THE EDGE OF THE SHIELDING COULD ALSO BE FOUND. OWING TO THE EFFECTIVENESS OF THE MITIGATIONS THAT ARE BUILT-IN TO THE DESIGN, THE REPORTED FAILURE IS NOT CONSIDERED LIKELY TO LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH IF THE EVENT WERE TO REOCCUR. THE DEVICE HAS PERFORMED AS DESIGNED IF A HARDWARE FAILURE IS ENCOUNTERED IN ORDER TO PROTECT AGAINST A FAULT BECOMING A HAZARD. IN CONCLUSION, THE DEVICE HAS ACTED AS DESIGNED AND INTENDED WHEN A SITUATION OCCURS WHICH COMPROMISES SAFE OPERATION, BY TRIGGERING AUDIBLE AND VISUAL ALARM. IT SHOULD BE NOTED THAT THE DEVICE IS MORE THAN 7 YEARS OLD AND THEREBY OUTSIDE ITS SPECIFIED SERVICE LIFE. HOWEVER THE BLOWER CABLES ARE NOT MOVING PARTS AND THEREFORE NOT AFFECTED BY MECHANICAL WEAR. THE CABLES COULD BE DAMAGED BY INCORRECT REASSEMBLY OF THE TOP COVER. DURING MANUFACTURE, THE CABLES ARE PROTECTED AND THE DEVICE IS TESTED. THE HOMECARE PROVIDER PERFORMED MAINTENANCE LATEST IN DECEMBER 2021, AT WHICH TIME THE FRONT COVER WAS REMOVED AND THEN REASSEMBLED, HENCE THE MOST PROBABLE CAUSE IS THAT THE CABLE DAMAGE WAS CAUSED DURING MAINTENANCE. THESE EVENTS ARE CONSIDERED NOT TO BE REPORTABLE PER MEDDEV 2.12/1 REV.8 AND 21 CFR 803 BECAUSE NO PATIENT INJURY WAS REPORTED, AND RISK MITIGATIONS WERE FOUND TO BE EFFECTIVE. HOWEVER, IT IS REPORTABLE IN GERMANY AS THE INCIDENT HAS OCCURRED DURING ACTIVE TREATMENT. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. BREAS MEDICAL AB WILL TRACK AND TREND FOR SIMILAR ISSUES.

    Description of Event or Problem · 0

    ALARM SOUNDED AND AN INTERNAL FUNCTION FAILURE 34 WAS DISPLAYED. SHORTLY AFTER THE VENTILATOR FAILED. THIS HAPPENED ON (B)(6) 2022. THE PATIENT INVOLVED WAS NOT INJURED DURING THE INCIDENT. INVESTIGATION: THE DEVICE WAS SENT TO BREAS MEDICAL GMBH AND ARRIVED 28TH OF JUNE 2022. ON THE NEXT DAY, BREAS MEDICAL GMBH STARTED THE EXAMINATION OF THE DEVICE. GENERAL INSPECTION SHOWED THAT THE DEVICE IS IN GOOD SHAPE. IT WAS RUNNING FOR 11745 OP. HOURS AND HAS FIRMWARE 2.16 LOADED. THE DEVICE WAS STARTED, A PRE-USE TEST WAS CARRIED OUT SUCCESSFULLY AND A TEST RUN WAS DONE ON A TEST LUNG USING THE PATIENT´S SETTINGS. THE POWER FAIL ALARM WAS CHECKED, IT WORKED AS INTENDED AND THE DEVICE GAVE AUDIBLE, WITH LEVEL FOR 85DB ±5DB THAT CANNOT BE CHANGED OR TURNED OFF, AND VISIBLE ALARMS. THE LOG FILES WERE DOWNLOADED AND EXAMINED WITH THE PC SOFTWARE VERSION 3.3.1.4. THE LOG FILES COULD ESTABLISH THAT TREATMENT WAS STARTED ON 14TH, JUNE 2022 ON MAINS POWER AT 12:51:19. ONE HOUR AND 12 MINUTES LATER C AT 14:03:03. THE DEVICE WAS RESTARTED BY DIS- AND RECONNECTING MAINS POWER AND STARTING TREATMENT AT 14:11:49. ERROR 34 REOCCURRED IMMEDIATELY AND PREVENTED A RESTART OF THE THERAPY. AT 14:17:58 A RESTART WAS TRIED AGAIN, PERFORMING A PRE-USE TEST THAT FAILED AND ERROR 34 OCCURRED AGAIN. THE DEVICE WAS SWITCHED OFF AT 14:22:36. CAUSE: FAULT TRACING OF THE DEVICE COULD NOT ESTABLISH A FAILURE DURING A BENCH TEST. THE VOLTAGE ON TEST POINT 52 (5 V ±0.25V) WAS CHECKED AGAINST GROUND (TP 65) AS RECOMMENDED BY THE SERVICE MANUAL AND FOUND TO BE FAULTLESS AT 4,95 VOLTS. A DAMAGE OF TWO BLOWER CABLES COULD BE IDENTIFIED DURING HARDWARE INSPECTION. THE ORANGE AND THE BLACK CABLE HAVE BEEN JAMMED BETWEEN THE EDGE OF THE HOUSING OF THE INTERNAL BATTERY BOX AND THE SHIELDING OF THE MAIN PROCESSOR OF THE CPU BOARD AND CAUSED A SHORTCUT ON THE SENSOR CABLE OF THE INTERNAL TEMPERATURE SENSOR OF THE BLOWER. BURN MARKS ON THE EDGE OF THE SHIELDING COULD ALSO BE FOUND. THE INNER CONDUCTORS HAVE ALMOST COMPLETELY BEEN CUT AND CAUSED THE DEVICE TO ALARM (ERROR 43 - THE BLOWER DOES NOT FUNCTION PROPERLY) AFTER INVESTIGATION AND REASSEMBLY AT BREAS MEDICAL GMBH. DUE TO THE DEVICE BEING MORE THAN 7 YEARS OLD AND THE PROVIDER LÖWENSTEIN HAVING PERFORMED MAINTENANCE LATEST IN DECEMBER 2021 ACCORDING TO THE LABELS FOUND IT IS POSSIBLE THAT THE DAMAGED WAS CAUSED BY A TECHNICIAN WHEN PERFORMING MAINTENANCE. NOTE: THE BLOWER IS STILL THE ORIGINAL ONE FROM 2014. THE BLOWER CABLES WERE RECONNECTED PROVISIONAL AND A PRE-USE TEST AND COMPLETE FUNCTION TEST INCLUDING CALIBRATION WAS PERFORMED WITH NO FAILURE. THE CUSTOMER WILL RECEIVE A COST ESTIMATE FOR THE REPLACEMENT OF THE BLOWER AND THE CPU BOARD. CONCLUSION AND ACTIONS: REVIEW OF THE DEVICE LOG FILES CONFIRMS THAT A FUNCTION FAILURE 34 (BLOWER TEMPERATURE IS BELOW -30°C) OCCURRED AND TERMINATED ACTIVE TREATMENT. AUDIBLE AND VISUAL ALARMS WERE CHECKED AND FOUND TO WORK AS INTENDED. THERE WAS NO PATIENT INJURY. FAULT TRACING OF THE DEVICE COULD ESTABLISH A HARDWARE FAILURE IN FORM OF DAMAGE OF TWO BLOWER CABLES. THE ORANGE AND THE BLACK CABLE HAVE BEEN JAMMED BETWEEN THE EDGE OF THE HOUSING OF THE INTERNAL BATTERY BOX AND THE SHIELDING OF THE MAIN PROCESSOR OF THE CPU BOARD AND CAUSED A SHORTCUT ON THE SENSOR CABLE OF THE INTERNAL TEMPERATURE SENSOR OF THE BLOWER. BURN MARKS ON THE EDGE OF THE SHIELDING COULD ALSO BE FOUND. OWING TO THE EFFECTIVENESS OF THE MITIGATION'S THAT ARE BUILT-IN TO THE DESIGN, THE REPORTED FAILURE IS NOT CONSIDERED LIKELY TO LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH IF THE EVENT WERE TO REOCCUR. THE DEVICE HAS PERFORMED AS DESIGNED IF A HARDWARE FAILURE IS ENCOUNTERED IN ORDER TO PROTECT AGAINST A FAULT BECOMING A HAZARD. IN CONCLUSION, THE DEVICE HAS ACTED AS DESIGNED AND INTENDED WHEN A SITUATION OCCURS WHICH COMPROMISES SAFE OPERATION, BY TRIGGERING AUDIBLE AND VISUAL ALARM. IT SHOULD BE NOTED THAT THE DEVICE IS MORE THAN 7 YEARS OLD AND THEREBY OUTSIDE ITS SPECIFIED SERVICE LIFE. HOWEVER THE BLOWER CABLES ARE NOT MOVING PARTS AND THEREFORE NOT AFFECTED BY MECHANICAL WEAR. THE CABLES COULD BE DAMAGED BY INCORRECT REASSEMBLY OF THE TOP COVER. DURING MANUFACTURE, THE CABLES ARE PROTECTED AND THE DEVICE IS TESTED. THE HOMECARE PROVIDER PERFORMED MAINTENANCE LATEST IN DECEMBER 2021, AT WHICH TIME THE FRONT COVER WAS REMOVED AND THEN REASSEMBLED, HENCE THE MOST PROBABLE CAUSE IS THAT THE CABLE DAMAGE WAS CAUSED DURING MAINTENANCE. THESE EVENTS ARE CONSIDERED NOT TO BE REPORTABLE PER MEDDEV 2.12/1 REV.8 AND 21 CFR 803 BECAUSE NO PATIENT INJURY WAS REPORTED, AND RISK MITIGATION'S WERE FOUND TO BE EFFECTIVE. HOWEVER, IT IS REPORTABLE IN GERMANY AS THE INCIDENT HAS OCCURRED DURING ACTIVE TREATMENT. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. BREAS MEDICAL AB WILL TRACK AND TREND FOR SIMILAR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291656 BREAS VIVO 50 RESPIRATORY THERAPY DEVICE (HOMECARE USE) NOU BREAS MEDICAL AB BREAS VIVO 50 07321822150005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other