BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 6986353 · Received October 30, 2017

    Report

    Report Number
    1218950-2017-07426
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    August 17, 2017
    Report Date
    October 4, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SERIAL NUMBER NOT PROVIDED. MEDWATCH NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED AVAILABLE INFORMATION WE CANNOT DETERMINE THE CAUSE OR RESOLUTION OF THE REPORTED ISSUE. THE CUSTOMER FILED A MEDWATCH, WITH NO DIRECT TO CALL TO PHILIPS. SEVERAL ATTEMPTS WERE MADE TO THE CUSTOMER FOR ADDITIONAL INFORMATION, WITH NO ADDITIONAL RESPONSES. PHILIPS RECEIVED SOME ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE PATIENT INFORMATION. DEVICE TESTING ANSWERS WERE WRITTEN AS "UNKNOWN". PHILIPS WILL CONSIDER THAT THE DEVICE MAY HAVE BEEN A FACTOR IN THE INCIDENT WITH THE PATIENT BASED ON THE FACT THAT INSUFFICIENT DETAILS WERE PROVIDED TO CONFIRM THE DEVICE WAS NOT A FACTOR. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT FELT THAT HE PASSED OUT. THE PATIENT WAS SHOWING VENTRICULAR STANDSTILL ON THE MONITOR BUT THE TELEMETRY FAILED TO PROVIDE A RED ALARM. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE FOR VENTRICULAR STANDSTILL. THE PATIENT WAS DISCHARGED ON (B)(6) 2017. THE INFORMATION INDICATES THAT URGENT MEDICAL INTERVENTIONS MAY HAVE BEEN REQUIRED. IF ALARMS ARE DELAYED, HARM IS POSSIBLE. THE PATIENT WAS SHOWING VENTRICULAR STANDSTILL ON THE MONITOR BUT THE TELEMETRY FAILED TO PROVIDE A RED ALARM. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE FOR VENTRICULAR STANDSTILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767527 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 CUSTOMER DID NOT PROVIDE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening