BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAS Z1

    MDR report key: 15347447 · Received September 2, 2022

    Report

    Report Number
    9617566-2022-00008
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    June 6, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BREAS MEDICAL INC.
    Product Code
    BZD
    PMA / PMN Number
    K140929
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER CUSTOMER COMPLAINT (B)(4) THE FOLLOWING WAS ALLEGED: "ON (B)(6) 2022 THE PATIENT BOUGHT THE DEVICE AT (B)(6) TO BE PREPARED FOR A FOLLOWING HOLIDAY. INSTANTLY AFTER THE USAGE DURING HER HOLIDAY IT TURNED OUT THAT THE DEVICE DOES NOT FULFILL THE EXPECTED REQUIREMENTS. DURING THIS HOLIDAY SHE SUFFERED FROM A SLIGHT STROKE. THE MEDICATED DOCTORS ARE SURE THAT THIS DEVICE IS MAINLY THE REASON FOR THIS OCCURRENCE." NOTE: THE EVENT IS UNCONFIRMED AT THIS POINT AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE INITIAL REPORTER. UPDATE 2022-09-02: THE FOLLOWING INFORMATION REGARDING THE INCIDENT WAS OBTAINED AFTER THE INITIAL REPORT: THE INCIDENT OCCURRED ON VACATION IN GREECE. THE PATIENT WOKE UP (B)(6) 2022 IN THE MORNING WITH A HANGING EYE AND MOUTH AND WAS NOT ABLE TO SPEAK. THE LOCAL HOSPITAL TOOK A CT AND SENT THE PATIENT TO A PRIVATE HOSPITAL WHERE A MRT WAS TAKEN WHICH CONFIRMED THAT THE PATIENT SUFFERED FROM A STROKE. A 5MM BLOOD CLOT WAS FOUND IN THE PATIENT'S HEAD. AN ATTENDED ADAC AIRCRAFT TOOK THE PATIENT HOME TO GERMANY. THE PATIENT THEN CONSULTED A FAMILY DOCTOR WHO INITIATED THE REHABILITATION. TODAY THE PATIENT HAS RECOVERED LARGELY AND ONLY STILL SUFFERS FROM A HANGING EYE WHICH IS CURRENTLY IN THERAPY. NOTICE FROM THE PATIENT: THE DEVICE DID DELIVER AIR, BUT SNORING WAS NOT STOPPED. IN THE PATIENT'S OPINION, THIS IS THE ROOT CAUSE FOR THE STROKE. A REPORT FROM THE FAMILY DOCTOR HAS YET TO BE RECEIVED. ANY OTHER REPORT FROM GREECE IS NOT AVAILABLE. THE Z1 DEVICE IN QUESTION WAS RETURNED TO BREAS FOR INVESTIGATION. THE INVESTIGATION HAS SHOWN THAT NO ANOMALIES WERE FOUND IN THE TREATMENT LOGS FROM THE DEVICE, AND THE BREAS DEVICE HAS PERFORMED IN ACCORDANCE WITH ITS SPECIFICATION. ACCORDING TO THE BREAS CLINICAL EVALUATION AND STATE-OF-THE-ART (SOTA), STROKE HAS NOT BEEN REPORTED AS A SIDE-EFFECT OF CPAP TREATMENT. FROM SOTA THE FOLLOWING INFORMATION CAN BE FOUND RELATED TO STROKE: OBSTRUCTIVE SLEEP APNEA (OSA) IS ASSOCIATED WITH AN INCREASED RISK OF STROKE. SOME STUDIES SUGGEST THAT CPAP TREATMENT MAY REDUCE THE RISK OF STROKE, BUT EVIDENCE LEVEL IS LOW. THERE IS NO EVIDENCE TO SUGGEST THAT CPAP TREATMENT WILL COMPLETELY PREVENT A PATIENT FROM HAVING A STROKE. BREAS CANNOT FIND ANY DATA IN THE LITERATURE THAT SNORING POTENTIALLY CAUSED BY A SHORT PERIOD OF TIME (A FEW NIGHTS) OF SUBOPTIMAL SETTING OF THE CPAP PRESSURE HAS AN INCREASED OR DECREASED IMPACT ON THE OCCURRENCE OF STROKE OR CARDIOVASCULAR EVENTS. OLDER DATA (PALOMAKI 1991) DESCRIBE SNORING AS AN INCREASED RISK FACTOR, BUT THESE AUTHORS POINT TO THE PRESENCE OF NON-TREATED OSA AND AS SUCH LONG-TERM SNORING. DATA FROM LEE ET AL (AASM 31.9.1207) DEMONSTRATE THAT HEAVY SNORING IS AN INDEPENDENT RISK FACTOR FOR EARLY CAROTID ATHEROSCLEROSIS, WHICH MAY PROGRESS TO BE ASSOCIATED WITH THE DEVELOPMENT OF STROKE, REPRESENTING A MAJOR CAUSE OF MORBIDITY AND MORTALITY. IN CONCLUSION, BREAS'S Z1 DEVICE WAS PERFORMING AS INTENDED, NO ANOMALIES WERE FOUND IN THE RETURNED DEVICE, AND THERE IS NO CLINICAL EVIDENCE TO SUGGEST THAT CPAP TREATMENT CAN CAUSE A STROKE NOR COMPLETELY PREVENT A PATIENT FROM HAVING A STROKE. CLINICAL ASSESSMENT HAS SHOWN THAT THERE IS NO KNOWN CAUSATIVE RELATIONSHIP BETWEEN CPAP TREATMENT AND STROKE. THIS IS CONSISTENT WITH BREAS CLINICAL EVALUATION FOR THE DEVICE. THE INVESTIGATION HAS SHOWN THAT NO ANOMALIES WERE FOUND IN THE TREATMENT LOGS FROM THE DEVICE, AND THE BREAS DEVICE HAS PERFORMED IN ACCORDANCE WITH ITS SPECIFICATION. THEREFORE, THE RISK ASSESSMENT FOR THE DEVICE REMAINS VALID. REVIEW OF MANUFACTURER'S COMPLAINT/INCIDENT FILES SHOW THAT NO SIMILAR INCIDENTS HAVE BEEN REPORTED TO BREAS.

    Description of Event or Problem · 0

    PER CUSTOMER COMPLAINT (B)(4) THE FOLLOWING WAS ALLEGED: "ON (B)(6) 2022 THE PATIENT BOUGHT THE DEVICE AT (B)(6) TO BE PREPARED FOR A FOLLOWING HOLIDAY. INSTANTLY AFTER THE USAGE DURING HER HOLIDAY IT TURNED OUT THAT THE DEVICE DOES NOT FULFILL THE EXPECTED REQUIREMENTS. DURING THIS HOLIDAY SHE SUFFERED FROM A SLIGHT STROKE. THE MEDICATED DOCTORS ARE SURE THAT THIS DEVICE IS MAINLY THE REASON FOR THIS OCCURRENCE." THE FOLLOWING INFORMATION REGARDING THE INCIDENT WAS OBTAINED AFTER THE INITIAL REPORT: THE INCIDENT OCCURRED ON VACATION IN GREECE. THE PATIENT WOKE UP (B)(6) 2022 IN THE MORNING WITH A HANGING EYE AND MOUTH AND WAS NOT ABLE TO SPEAK. THE LOCAL HOSPITAL TOOK A CT AND SENT THE PATIENT TO A PRIVATE HOSPITAL WHERE A MRT WAS TAKEN WHICH CONFIRMED THAT THE PATIENT SUFFERED FROM A STROKE. A 5MM BLOOD CLOT WAS FOUND IN THE PATIENT'S HEAD. AN ATTENDED ADAC AIRCRAFT TOOK THE PATIENT HOME TO GERMANY. THE PATIENT THEN CONSULTED A FAMILY DOCTOR WHO INITIATED THE REHABILITATION. TODAY THE PATIENT HAS RECOVERED LARGELY AND ONLY STILL SUFFERS FROM A HANGING EYE WHICH IS CURRENTLY IN THERAPY. NOTICE FROM THE PATIENT: THE DEVICE DID DELIVER AIR, BUT SNORING WAS NOT STOPPED. IN THE PATIENT'S OPINION, THIS IS THE ROOT CAUSE FOR THE STROKE. A REPORT FROM THE FAMILY DOCTOR HAS YET TO BE RECEIVED. ANY OTHER REPORT FROM GREECE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831870 BREAS Z1 VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE: BZD BZD BREAS MEDICAL INC. BREAS Z1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other