BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVO 65

    MDR report key: 18299585 · Received December 11, 2023

    Report

    Report Number
    9617566-2023-00006
    Event Type
    Death
    Date Received
    December 11, 2023
    Date of Event
    November 27, 2023
    Report Date
    November 12, 2023
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822250002
    PMA / PMN Number
    K160481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN THE DEVICE WAS EXAMINED BY THE DISTRIBUTOR, IT WAS FOUND THAT THE DEVICE MEMORY HAD BEEN ERASED ON (B)(6) 2023. THIS MEANS THAT THE EVENT LOGS FOR THE PERIOD OF THE EVENT CANNOT BE ANALYZED. BREAS REQUESTED TO HAVE THE DEVICE RETURNED FOR INSPECTION AND TESTING. THE DEVICE IS OWNED BY THE TÜRKIYE MINISTRY OF HEALTH. WHEN THE DISTRIBUTOR REQUESTED PERMISSION TO SEND THE DEVICE TO BREAS, THIS WAS DECLINED BY THE FAMILY. THEREFORE IT WILL NOT BE POSSIBLE TO INVESTIGATE THIS EVENT FURTHER AND CONCLUDE ON A ROOT CAUSE. ACCORDING TO THE NARRATIVE PROVIDED BY THE DISTRIBUTOR, THE DEVICE MAY HAVE OVERHEATED DUE TO A FILTER PROBLEM, AND IT ALARMED WITH INTERNAL FUNCTION FAILURE AS INTENDED. THE PATIENT WAS VENTILATED MANUALLY WITH A VENTILATION BAG (AMBU). CPR WAS PERFORMED FOR A TOTAL OF 45 MINUTES BUT THE PATIENT COULD NOT BE RESUSCITATED. INTERNAL FUNCTION FAILURE 18 MEANS "5 V OR 12 V ON PSU BOARD IS OUT OF RANGE". THE RECOMMENDED ACTION IN THE SERVICE MANUAL IS 1) RESTART THE DEVICE, 2) CHECK RIBBON CABLE BETWEEN CPU BOARD AND PSU BOARD, AND 3 REPLACE THE PSU BOARD OR SEND THE VIVO 55/65 FOR SERVICE (BY THE MANUFACTURER.) THE DISTRIBUTOR WAS ABLE TO RESTART THE DEVICE AFTER INSPECTION. THE DEVICE ALARMED WITH FUNCTION FAILURE ERROR 18 DURING ACTIVE TREATMENT. HAZARDOUS SITUATION IS THEREFORE: 10.400.160_CRIT_COMPLETE LOSS OF VENTILATION. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CLASSIFIED AS CRITICAL SINCE THE TREATMENT WAS TERMINATED WITH AUDIBLE AND VISUAL ALARM. THIS FAILURE CANNOT BE REPRODUCED, AND THE INVESTIGATION CANNOT BE PURSUED FURTHER AS NEITHER THE EVENT HISTORY LOG OR THE ACTUAL DEVICE ARE AVAILABLE. RISK EVALUATION: BASED ON THE INFORMATION RECEIVED, THE FAILURE IS NOT CONSIDERED LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY/DETERIORATION OF HEALTH IF THE EVENT WERE TO REOCCUR. THE DEVICE HAS PERFORMED AS DESIGNED AND INTENDED, THE DEVICE GAVE A HIGH PRIORITY AUDIBLE AND VISUAL ALARM. THE PATIENT WAS SUPERVISED BY A CAREGIVER AND THE DEATH OF THE PATIENT OCCURRED AFTER BEING MANUALLY VENTILATED WITH EMERGENCY EQUIPMENT (E.G. RESUSCITATION BAG) AS REQUIRED BY THE INSTRUCTIONS FOR USE. RISK MITIGATION'S CURRENTLY IN PLACE ARE THEREFORE CONSIDERED EFFECTIVE TO MAINTAIN THE FINAL RISK LEVEL AT AFAP RISK REDUCED (AS FAR AS POSSIBLE). DECISION RATIONALE: BASED ON THE INFORMATION PROVIDED, CONFIRMING EXISTING MITIGATION'S ARE FOUND EFFECTIVE, THIS COMPLAINT HAS BEEN REVIEWED AND EVALUATED IN ACCORDANCE WITH CTR-0090. THE EVENT HAS BEEN DEEMED REPORTABLE PER THE APPLICABLE REGULATORY REQUIREMENTS (SEE REQUIREMENTS REVIEWED). THE EVENT DOES NOT CONSTITUTE A SERIOUS PUBLIC HEALTH THREAT. THE REPORT CONFIRMS THAT THE PATIENT INVOLVED DID NOT RECEIVE ANY INJURY. IN ADDITION, COMPLAINT TRENDING IS USED TO DETECT UNEXPECTED RISES IN THE P1 VALUE (P1 = PROBABILITY OF OCCURRENCE) TO TRIGGER FUTURE INVESTIGATIONS, AS REQUIRED. TRACK AND TREND FOR SIMILAR COMPLAINTS. NO FURTHER INVESTIGATION IS POSSIBLE. COMPLAINT CAN BE CLOSED.

    Additional Manufacturer Narrative · 0

    BREAS MEDICAL AB HAS ASKED THE DISTRIBUTOR TO SEND BACK THE DEVICE INVOLVED IN THE INCIDENT IN ORDER TO PERFORM A THOROUGH TECHNICAL ANALYSIS.

    Description of Event or Problem · 0

    ON 27 NOVEMBER 2023; BREAS MEDICAL AB WAS INFORMED THAT A DEVICE MANUFACTURED BY THE COMPANY HAS BEEN INVOLVED IN AN INCIDENT IN TURKEY. DESCRIPTION OF THE INCIDENT AS PROVIDED BY THE DISTRIBUTOR: "TODAY, AT 03.55 TURKEY TIME, THE VIVO 65 VENTILATOR DEVICE GAVE AN INTERNAL FUNCTION FAILURE 18 WARNING. WE WENT TO INTERVENE ON THE DEVICE, BUT THE PATIENT PASSED AWAY. COULD YOU PLEASE SHARE A DOCUMENT WHERE WE CAN LEARN THE SOURCE OF THIS WARNING AND THE REASON FOR ALL OTHER WARNINGS?" ALSO FOLLOWING INFORMATION WAS PROVIDED: "AT NIGHT, THE PATIENT'S RELATIVE LEFT US A FAULT REPORT. WE WENT TO THE SCENE WITHIN HALF AN HOUR, BUT CPR WAS STARTED WHEN WE ARRIVED. DEATH OCCURRED AFTER WAITING AT THE SCENE FOR 20 MINUTES." THE FOLLOWING ADDITIONAL DESCRIPTION WAS PROVIDED BY THE DISTRIBUTOR: AT (GMT+3)3:55 A.M. TURKISH TIME, THE PATIENT'S RELATIVE CALLED ME SAYING THAT THE DEVICE HAD AN INTERNAL FUNCTION ERROR. HE SAID THAT THE DEVICE WAS NOT WORKING AND WAS GIVING A WARNING. I INVITED HIM TO A VIDEO CALL TO SEE THE DEVICE. DURING THE VIDEO CALL, THE PATIENT WAS TAKEN INTO AMBU AND HEART MASSAGE WAS STARTED. I ARRIVED AT THE HOSPITAL WITHIN HALF AN HOUR. DURING THIS TIME, THE DEVICE WAS COMPLETELY TURNED OFF. I DID A PRELIMINARY CHECK OF THE DEVICE, THE DEVICE WAS EXTREMELY HOT, I THINK THIS IS DUE TO THE FILTER. MEANWHILE, THE PATIENT WAS STILL RECEIVING HEART MASSAGE. CPR WAS PERFORMED FOR A TOTAL OF 45 MINUTES, BUT HE DIED. AFTER RECEIVING THE DEVICE, I TOOK IT FOR A GENERAL CHECK-UP IN THE OFFICE AROUND 4 A.M. AND REPORTED THAT THE DEVICE DID NOT ACTIVATE AT FIRST, BUT THEN STARTED WORKING.

    Description of Event or Problem · 0

    ON (B)(6) 2023; BREAS MEDICAL AB WAS INFORMED THAT A DEVICE MANUFACTURED BY THE COMPANY HAS BEEN INVOLVED IN AN INCIDENT IN TURKEY. DESCRIPTION OF THE INCIDENT AS PROVIDED BY THE DISTRIBUTOR: "TODAY, AT 03.55 TURKEY TIME, THE VIVO 65 VENTILATOR DEVICE GAVE AN INTERNAL FUNCTION FAILURE 18 WARNING. WE WENT TO INTERVENE ON THE DEVICE, BUT THE PATIENT PASSED AWAY. COULD YOU PLEASE SHARE A DOCUMENT WHERE WE CAN LEARN THE SOURCE OF THIS WARNING AND THE REASON FOR ALL OTHER WARNINGS?" ALSO FOLLOWING INFORMATION WAS PROVIDED: "AT NIGHT, THE PATIENT'S RELATIVE LEFT US A FAULT REPORT. WE WENT TO THE SCENE WITHIN HALF AN HOUR, BUT CPR WAS STARTED WHEN WE ARRIVED. DEATH OCCURRED AFTER WAITING AT THE SCENE FOR 20 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940369 VIVO 65 EXTRA HOSPITAL PORTABLE VENTILATORS NOU BREAS MEDICAL AB VIVO 65 07321822250002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death