BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEMETRY SYSTEM: MINDRAY HYPERVISOR VI WITH MODEL TEL-100 PACKS

    MDR report key: 15121313 · Received July 27, 2022

    Report

    Report Number
    MW5111149
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    July 23, 2022
    Report Date
    July 25, 2022
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT. ON A CARDIZEM DRIP BEING MONITORED USING TELEMETRY. HIS MONITOR SKIPS OUT READING SATURATED SIGNAL OR RF SIGNAL. THE PROBLEM APPEARS TO BE UNPREDICTABLE INTERFERENCE OF THE 608-614 MHZ BAND WIDTH FREQUENCY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427032 TELEMETRY SYSTEM: MINDRAY HYPERVISOR VI WITH MODEL TEL-100 PACKS MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male