BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER FLEX CARDIO 2010 REV D

    MDR report key: 10623561 · Received October 2, 2020

    Report

    Report Number
    1051786-2020-00048
    Event Type
    Death
    Date Received
    October 2, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 29, 2020
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838083820
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ECG CURVE WOULD EXHIBIT ARTIFACT (NOISE / INTERFERENCE), AND SOMETIMES THE WRONG HEART RATE MEASUREMENT. THE CUSTOMER DID NOT ALLEGE THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO THE PATIENT¿S OUTCOME, NOR WAS TREATMENT OF THE PATIENT DELAYED AS A RESULT OF THE INCIDENT. NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. HOWEVER, ONSITE FIELD SERVICE WAS UNABLE TO CONFIRM THE REPORTED PROBLEM DURING HIS EVALUATION. THE FSE SUSPECTS THAT THE ECG ISSUE WAS LIKELY CAUSED BY THE EXTERNAL STIMULATION USED BY THE CUSTOMER. THIS WAS ALSO INDICATED IN THE LOG FILE REVIEW. THE FSE PROACTIVELY INSTALLED TWO (2) FERRITES ON THE POWER CORD TO MINIMIZE ANY POTENTIAL ARTIFACT AND CONFIRMED THE SYSTEM'S FUNCTIONALITY. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CONTRIBUTED IN ANY WAY TO THE PATIENT¿S OUTCOME. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S FACILITY. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE 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 · 0

    IT WAS REPORTED TO PHILIPS THAT, ON A PATIENT WITH AN EXTERNAL STIMULATION, THE ECG WAVES ARE VERY SPIKEY, AND DURING A SHORT PERIOD DISAPPEARED. THE PATIENT PASSED AWAY.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT, ON A PATIENT WITH AN EXTERNAL STIMULATION, THE ECG WAVES ARE VERY SPIKEY, AND DURING A SHORT PERIOD DISAPPEARED. THE PATIENT REPORTEDLY PASSED AWAY. WE ARE IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083119 XPER FLEX CARDIO 2010 REV D XPER FLEX CARDIO PHYSIOMONITORING SYSTEM MWI INVIVO CORPORATION FC2010 N/A 00884838083820

    Patients

    Seq Age Sex Outcome Treatment
    1 Death