BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 9612635 · Received January 21, 2020

    Report

    Report Number
    1218950-2020-00438
    Event Type
    Death
    Date Received
    January 21, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 20, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: GOOD FAITH EFFORT WAS MADE TO DETERMINE IF THE DEVICE WILL BE RETURNED FOR EVALUATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE HOSPITAL'S BIOMED CONCLUDED THE DEVICE FUNCTIONED AS INTENDED. "THE EVENT WAS NOT RELATED TO ANY UNEXPECTED FAILURE OF PHILIPS EQUIPMENT.PHILIPS EQUIPMENT DID WHAT IT WAS SUPPOSED TO DO, NO ISSUES WITH THE OPERATION OF THE EQUIPMENT." PG 135-136 OF THE INSTRUCTIONS FOR USE (IFU) CONTAINS INFORMATION ON BATTERY POWER INCLUDING LIFETIME MANAGEMENT. THE HOSPITAL'S BIOMED STATED, "WE HAVE IT WORKED OUT. FROM THE EQUIPMENT SIDE ALL IS WORKING. IT¿S UP TO NURSING NEXT STEPS FOR MONITORING." THE DEVICE REMAINS AT THE CUSTOMER SITE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3 OTHER TEXT : THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE'S BATTERY DIED DURING THE NIGHT WITHOUT ANYONE'S KNOWLEDGE. THE CUSTOMER STATES THE PATIENT WAS FOUND SIX (6) HOURS LATER WITH NO PULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76761 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 Death