BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITORING SERVICE APPLICATION (MSA)

    MDR report key: 20541721 · Received October 28, 2024

    Report

    Report Number
    3003584029-2024-00089
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    February 7, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DQK
    Removal / Correction Number
    Z-0708-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MISSED ARRHYTHMIC EVENT WITH NO NEW FINDING. THE BRAEMAR TELEMETRY PATCH SYSTEM BTPS-1000 TRANSMITS ECG TRACING(S) TO A MONITORING APPLICATION FOR PRELIMINARY REVIEW BY A CARDIOLOGY TECHNICIAN AND SUBSEQUENT NOTIFICATION OR REPORTING TO THE TREATING CLINICIAN BASED ON THE TECHNICIAN FINDINGS. THE INVESTIGATION CONCLUDED THAT THE MONITORING APPLICATION DID NOT PRESENT AN ECG TRACING(S) CONTAINING AN ARRHYTHMIC EVENT TO A CARDIOLOGY TECHNICIAN, HOWEVER, THE EVENT DID NOT MEET CRITERIA FOR CLINICIAN-DEFINED NOTIFICATION OR REPRESENTATION ON THE DAILY AND END OF SERVICE REPORTS AND, THEREFORE, WOULD NOT HAVE BEEN PROVIDED TO THE HEALTHCARE PROVIDER (HCP). NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS KNOWN. NEITHER THE BRAEMAR TELEMETRY PATCH SYSTEM BTPS-1000 NOR THE MONITORING APPLICATION PROVIDE A DIAGNOSIS OR TREATMENT RECOMMENDATION. INSTEAD, THE HCP DETERMINES A TREATMENT PLAN FOR THE PATIENT BASED ON THE INFORMATION PROVIDED. THIS SYSTEM IS NOT INTENDED FOR USE AS AN EMERGENCY RESPONSE SYSTEM FOR PATIENTS WHO MAY EXPERIENCE SERIOUS OR LIFE-THREATENING ARRHYTHMIAS. THE CAUSE OF THE PATIENT DEATH IS UNKNOWN, BUT THE INVESTIGATION DID NOT IDENTIFY ANY EVIDENCE TO SUGGEST THE SYSTEM WAS A FACTOR. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, BRAEMAR MANUFACTURING, LLC, OR OUR EMPLOYEES, HAVE CAUSED OR CONTRIBUTED TO THE EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED WHEN REPORTED TO BRAEMAR MANUFACTURING, LLC AND DOES NOT IMPLY OR MEAN THAT THE INFORMATION AS REPORTED HEREIN IS ACCURATE OR HAS BEEN CONFIRMED BY BRAEMAR MANUFACTURING, LLC. FOLLOW UP REPORT #1, SUBMITTED TO ENTER THE RECALL NUMBER ASSIGNED BY FDA.

    Additional Manufacturer Narrative · 0

    MISSED ARRHYTHMIC EVENT WITH NO NEW FINDING. THE BRAEMAR TELEMETRY PATCH SYSTEM BTPS-1000 TRANSMITS ECG TRACING(S) TO A MONITORING APPLICATION FOR PRELIMINARY REVIEW BY A CARDIOLOGY TECHNICIAN AND SUBSEQUENT NOTIFICATION OR REPORTING TO THE TREATING CLINICIAN BASED ON THE TECHNICIAN FINDINGS. THE INVESTIGATION CONCLUDED THAT THE MONITORING APPLICATION DID NOT PRESENT AN ECG TRACING(S) CONTAINING AN ARRHYTHMIC EVENT TO A CARDIOLOGY TECHNICIAN, HOWEVER, THE EVENT DID NOT MEET CRITERIA FOR CLINICIAN-DEFINED NOTIFICATION OR REPRESENTATION ON THE DAILY AND END OF SERVICE REPORTS AND, THEREFORE, WOULD NOT HAVE BEEN PROVIDED TO THE HEALTHCARE PROVIDER (HCP). NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS KNOWN. NEITHER THE BRAEMAR TELEMETRY PATCH SYSTEM BTPS-1000 NOR THE MONITORING APPLICATION PROVIDE A DIAGNOSIS OR TREATMENT RECOMMENDATION. INSTEAD, THE HCP DETERMINES A TREATMENT PLAN FOR THE PATIENT BASED ON THE INFORMATION PROVIDED. THIS SYSTEM IS NOT INTENDED FOR USE AS AN EMERGENCY RESPONSE SYSTEM FOR PATIENTS WHO MAY EXPERIENCE SERIOUS OR LIFE-THREATENING ARRHYTHMIAS. THE CAUSE OF THE PATIENT DEATH IS UNKNOWN, BUT THE INVESTIGATION DID NOT IDENTIFY ANY EVIDENCE TO SUGGEST THE SYSTEM WAS A FACTOR. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, BRAEMAR MANUFACTURING, LLC, OR OUR EMPLOYEES, HAVE CAUSED OR CONTRIBUTED TO THE EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED WHEN REPORTED TO BRAEMAR MANUFACTURING, LLC AND DOES NOT IMPLY OR MEAN THAT THE INFORMATION AS REPORTED HEREIN IS ACCURATE OR HAS BEEN CONFIRMED BY BRAEMAR MANUFACTURING, LLC.

    Description of Event or Problem · 0

    MISSED ARRHYTHMIC EVENT WITH NO NEW FINDING. THE PATIENT EXPERIENCED AN ARRHYTHMIC EVENT(S) THAT WAS NOT PRESENTED FOR PRELIMINARY REVIEW DURING THE MONITORING PERIOD. HOWEVER, THIS ARRHYTHMIC EVENT DID NOT MEET CLINICIAN-DEFINED NOTIFICATION CRITERIA, NOR DID IT MEET CRITERIA FOR REPRESENTATION ON THE DAILY AND END OF SERVICE REPORTS. BRAEMAR MANUFACTURING, LLC BECAME AWARE OF THE PATIENT DEATH IN ACCORDANCE WITH STANDARD PRACTICES AT THE END OF THE MONITORING PERIOD.

    Description of Event or Problem · 0

    MISSED ARRHYTHMIC EVENT WITH NO NEW FINDING. THE PATIENT EXPERIENCED AN ARRHYTHMIC EVENT(S) THAT WAS NOT PRESENTED FOR PRELIMINARY REVIEW DURING THE MONITORING PERIOD. HOWEVER, THIS ARRHYTHMIC EVENT DID NOT MEET CLINICIAN-DEFINED NOTIFICATION CRITERIA, NOR DID IT MEET CRITERIA FOR REPRESENTATION ON THE DAILY AND END OF SERVICE REPORTS. BRAEMAR MANUFACTURING, LLC BECAME AWARE OF THE PATIENT DEATH IN ACCORDANCE WITH STANDARD PRACTICES AT THE END OF THE MONITORING PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725515 MONITORING SERVICE APPLICATION (MSA) MONITORING SERVICE APPLICATION (MSA) DQK BRAEMAR MANUFACTURING, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male