BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 4921570 · Received July 17, 2015

    Report

    Report Number
    1218950-2015-03780
    Event Type
    Death
    Date Received
    July 17, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE ON (B)(6) 2015 AND WAS TOLD BY THE CUSTOMER'S BIOMEDICAL ENGINEER THAT THEY DID NOT WANT PHILIPS TO EVALUATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT. THE BIOMED STATED THAT THEY WERE GOING TO DO AN INTERNAL INVESTIGATION AND DID NOT REQUIRE PHILIPS TESTING OF THE DEVICE. SINCE THE CUSTOMER WOULD NOT ALLOW PHILIPS TO EVALUATE THE DEVICE WE CANNOT CONFIRM THAT THE DEVICE WAS OPERATING PER SPECIFICATIONS. THE DEVICE REMAINS AT THE CUSTOMER SITE. A PATIENT DEATH OCCURRED. THE CUSTOMER REPORTED THAT THE PACER DETECTION WAS NOT TURNED ON FOR A PACED PATIENT AND THE MX40 TELEMETRY DEVICE FAILED TO ALARM FOR AN ASYSTOLE EVENT RESULTING IN A PATIENT DEATH. STRIPS WERE PROVIDED FOR (B)(4) ON (B)(6) 2015 FROM 18:44 TO 18:50 TIMEFRAME. THE STRIPS DEMONSTRATE THAT PACED MODE WAS SET FOR: NOT PACED AT 18:44 ON (B)(6) 2015 A PACED RHYTHM IS SHOWN WITH "N" FOR NORMAL BEAT LABELS INSTEAD OF "P" FOR PACED WHICH IS WHAT WOULD BE EXPECTED FOR A PACED RHYTHM WHEN PACING IS TURNED ON. STRIP SHOWS OCCASIONAL FAILURE TO CAPTURE WITH PACE PULSE SHOWN BUT NO CAPTURED BEAT. AT 18:47 THERE ARE INCREASING FAILED CAPTURE WITH ABSENT QRSS. PACER SPIKES ARE BEING LABELED AS "A" OR "V" AS THE SYSTEM ATTEMPTS TO CLASSIFY THESE AS BEATS. AT 18:50 THE HR IS LISTED AS 68 WHICH IS REFLECTING ONLY SPIKES. THERE ARE ONLY 3 CAPTURED BEATS ON THE PAGE IN APPROXIMATELY A 20 SECOND TIMEFRAME. THE STRIPS ARE CONSISTENT WITH BEHAVIOR WHEN PACING IS NOT TURNED ON. PRODUCT LABELING PROVIDES EXPLICIT WARNINGS ABOUT THE IMPORTANCE OF ENABLING PACED MODE FOR PACED PATIENTS TO AVOID SUCH OCCURRENCES. THE INFORMATION IS NOT CONSISTENT WITH ANY PRODUCT MALFUNCTION. THE ISSUE IS CONSISTENT WITH A USE ISSUE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACER DETECTION WAS NOT TURNED ON FOR A PACED PATIENT AND THE MX40 TELEMETRY DEVICE FAILED TO ALARM FOR AN ASYSTOLE EVENT RESULTING IN A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465764 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