BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTEL MCOT

    MDR report key: 16051217 · Received December 23, 2022

    Report

    Report Number
    MW5114003
    Event Type
    Death
    Date Received
    December 23, 2022
    Date of Event
    December 3, 2022
    Report Date
    December 22, 2022
    Manufacturer
    BIOTEL/BRAEMAR MANUFACTURING, LLC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE SWITCHED TO CELLULAR USE AND DID NOT CAPTURE EKG ON PATIENT. A 77 YEAR OLD FEMALE PATIENT WAS ADMITTED TO TELEMETRY UNIT FOR CARDIAC ISSUES. CARDIOLOGY WAS CONSULTED AND DECISION WAS MADE TO MONITOR CARDIAC ACTIVITY AS OUTPATIENT. HOWEVER, PATIENT SUFFERED SECOND CARDIAC EVENT DURING ADMISSION AND WAS NOT ABLE TO BE RESUSCITATED. PATIENT WAS BEING MONITORED ON TELEMETRY UNIT AT THAT TIME AT THE TIME OF THE EVENT, BUT WAS ALSO WEARING THE MCOT DEVICE. THE DEVICE DID NOT CONTRIBUTE TO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050556 BIOTEL MCOT DETECTOR AND ALARM, ARRHYTHMIA DSI BIOTEL/BRAEMAR MANUFACTURING, LLC. MT29110048

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death