BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 14829583 · Received June 27, 2022

    Report

    Report Number
    1218950-2022-00518
    Event Type
    Death
    Date Received
    June 27, 2022
    Date of Event
    May 31, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL AUDIT LOGS WERE PROVIDED AND WERE REVIEWED BY THE PHILIPS CLINICAL PRODUCT SPECIALIST. THE CLINICAL PRODUCT SPECIALIST (CPS) ANALYZED THE CLINICAL AUDIT LOGS AND NOTED THAT THERE MANY YELLOW AND RED ALARMS LEADING TO THE TIME OF TREATMENT 13:00. THE CPS INDICATED THAT THE ALARMS WERE GENERATED APPROPRIATELY AND WERE ACKNOWLEDGED BY THE TELE TECHNICIAN. THE CLINICAL PRODUCT SPECIALIST DETERMINED THAT THERE WAS NO MALFUNCTION OF THE PHILIPS DEVICE AS THE DEVICE WAS FUNCTIONING AS DESIGNED. BASED ON THE LOG INFORMATION, THE DEVICE DID ALARM WHEN IT WAS SUPPOSED TO. BASED ON THE PERFORMED INVESTIGATION, PHILIPS HAS DETERMINED THAT HE MX40 DEVICE WORKING AS INTENDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO ALARM WHEN THERE WAS A CHANGE OF RHYTHM AND RATE, WHICH LED TO A BRADYCARDIC EVENT. THE DEVICE WAS IN USE AND A PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704673 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS NORTH AMERICA LLC 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death