BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL DEVICE INTEGRATER SMARTLINX AXON 110

    MDR report key: 12844162 · Received November 18, 2021

    Report

    Report Number
    MW5105468
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 17, 2021
    Manufacturer
    CAPSULE TECH, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE ARE USING DIFFERENT PIECES OF HARDWARE FROM CAPSULE, ONE FOR WIRELESS SURVEILLANCE (AXON), AND ONE FOR HARDWIRED SURVEILLANCE (NEURON). THE AXON IS INTERMITTENTLY DISCONNECTING FROM OUR NETWORK AND REQUIRES A MANUAL REBOOT OF THE DEVICE TO RESOLVE. CAPSULE IS INVESTIGATING, BUT HAS NOT PROVIDED A ROOT CAUSE, NOR A MITIGATION SOLUTION. THIS IS A DIRECT PATIENT SAFETY ISSUE. CAPSULE JUST INFORMED US THAT THERE WAS AN ISSUE UNCOVERED WITH THE WIRELESS DRIVER IN THE AXON CRASHING AT ANOTHER CUSTOMER SITE OVER A YEAR AGO. THEY INVESTIGATED AND NEVER WERE ABLE TO REPRODUCE OUTSIDE OF THE CUSTOMER ENVIRONMENT. THEY CAME UP WITH A WORKAROUND THAT RESTARTS THE AXON, AND THIS WAS GOOD ENOUGH FOR THAT CUSTOMER, SO CAPSULE DID INTO INVESTIGATE FURTHER. IN THEIR INVESTIGATION OF OUR ISSUES THAT CONFIRMED THAT THIS CRASHING IS HAPPENING HERE AND IS PART OF WHAT IS CONTRIBUTING TO OUR DISCONNECTIONS/INTERRUPTIONS IN SURVEILLANCE. THE WORKAROUND THAT WAS PUT IN PLACE TO RESTART THE AXONS IS IN PLACE ON OUR DEVICES, BUT IT OBVIOUSLY NOT A SUFFICIENT WORKAROUND FOR OUR CIRCUMSTANCE. I AM SHOCKED THAT CAPSULE NEVER INFORMED ANY CUSTOMERS OF POTENTIAL ISSUES WITH THE AXON. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737211 MEDICAL DEVICE INTEGRATER SMARTLINX AXON 110 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MHX CAPSULE TECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown