BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 8483846 · Received April 4, 2019

    Report

    Report Number
    1218950-2019-02583
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 6, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER STATED THAT THIS TELEBOX WAS ISOLATED ON 3A BY NURSING STAFF AND WAS PUT ASIDE TO BE CHECKED BY CE STAFF. THE 3A UNIT COORDINATOR STATED THAT NURSE TOLD HER THAT PATIENT HAD AN ARRYTHMIA THAT DIDN¿T DISPLAY ON THE CENTRAL MONITOR. THE BOX WAS CONNECTED TO A FLUKE PROSIM 4 SIMULATOR, AND THE BOX FUNCTIONED NORMALLY AS DESIGNED. THE BOX DETECTED, RECORDS, AND DISPLAYED ECG AS DESIGNED. WHEN THE LA LEAD WAS REMOVED FROM THE SIMULATOR, THE BOX DISPLAYED "LEADS OFF". VOLUME, ASYSTOLE, HYPOTENSIVE, LOW BRADY, SINUS TACHYCARDIA, ECG AND AFIB SIMULATIONS WERE RUN AND NO ISSUES COULD BE FOUND WITH THE FUNCTIONALITY OR INTEGRITY OF THIS TELEBOX. THE BIOMED FOUND NO TROUBLE WITH THE DEVICE AND RETURNED IT TO SERVICE AFTER HIS EVALUATION. THE CAUSE OF THE INCIDENT REMAINS UNKNOWN. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER, (B)(6) , ALLEGED THAT THE TELEMETRY DEVICE HAD FAILED TO PROVIDE ALARMS FOR A PATIENT IN ARRHYTHMIA AS VIEWED ON THE CENTRAL STATION SECTOR. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE ICU TO ADDRESS THEIR ARRHYTHMIA ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274688 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention