BEUDAMED
    FDA Adverse Event Death Summary report: N

    TM80

    MDR report key: 21154055 · Received January 14, 2025

    Report

    Report Number
    3009156722-2025-00001
    Event Type
    Death
    Date Received
    January 14, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 28, 2025
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MSX
    PMA / PMN Number
    K220058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MINDRAY FIELD SERVICE REPRESENTATIVE COLLECTED SYSTEM LOGS AND PATIENT DATABASE FOR INVESTIGATION. MINDRAY EVALUATED THE DATA AND CONFIRMED THAT THE TM80 USED WITH THE BENEVISION DMS PERFORMED PER SPECIFICATIONS. MINDRAY'S TM80 TELEMETRY MONITOR AND THE BENEVISION DMS SERVER GENERATED THE CORRESPONDING ALARMS NORMALLY. HOWEVER, BECAUSE THE USER HAD THE WORKSTATION IN LOCAL STANDBY MODE FOR THE TM80 THAT WAS ACTIVELY MONITORING THE PATIENT, THE CORRESPONDING ALARMS WERE NOT DISPLAYED AT THE WORKSTATION.

    Additional Manufacturer Narrative · 0

    MINDRAY FIELD SERVICE REPRESENTATIVE COLLECTED SYSTEM LOGS AND PATIENT DATABASE FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    NO ALLEGED MALFUNCTION WAS REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT ON (B)(6) 2024, AT 16:54 (4:54 PM), A PATIENT WAS PLACED ON THE TM80 TELEMETRY MONITOR CONNECTED TO A BENEVISION DMS, HAD VENTRICULAR TACHYCARDIA (V-TACH)/VENTRICULAR FIBRILLATION (V-FIB) TO ASYSTOLE EPISODES, CONTINUED UNTIL 17:56 (5:56 PM). THE ALARM WAS ALLEGEDLY SILENCED AT THE WORKSTATION. CODE WAS CALLED AND CHEST COMPRESSIONS STARTED. PATIENT EXPIRED.

    Description of Event or Problem · 0

    NO ALLEGED MALFUNCTION WAS REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT ON (B)(6) 2024, AT 16:54 (4:54 PM), A PATIENT WAS PLACED ON THE TM80 TELEMETRY MONITOR CONNECTED TO A BENEVISION DMS, HAD VENTRICULAR TACHYCARDIA (V-TACH)/VENTRICULAR FIBRILLATION (V-FIB) TO ASYSTOLE EPISODES, CONTINUED UNTIL 17:56 (5:56 PM). THE ALARM WAS ALLEGEDLY SILENCED AT THE WORKSTATION. CODE WAS CALLED AND CHEST COMPRESSIONS STARTED. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516670 TM80 TM80 TELEMETRY UNIT MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TM80 MAIN UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death