BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERIM HARDWARE

    MDR report key: 12753672 · Received November 4, 2021

    Report

    Report Number
    1218950-2021-11070
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 11, 2021
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838084919
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUBSEQUENT INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT, THE PROCEDURE BEING PERFORMED WAS A TEE/CARDIOVERSION (TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WITH CARDIOVERSION) DONE IN PRE/POST ROOM 4 ON (B)(6) 2021. FOR THIS CASE, END USERS HAD "SPLIT" THE SCREEN, WITH CHARTING ON ONE HALF OF THE SCREEN AND HEMO (MONITORING) ON THE OTHER. ACCORDING TO THE CUSTOMER, THERE WAS NO PATIENT HARM, BUT THE PATIENT WAS SEDATED, AND THERE WAS A DELAY IN MONITORING WHILE THE DEVICE WAS REBOOTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO ADDRESS THE REPORTED PROBLEM. THE DEVICE EVALUATION WAS PERFORMED BY THE FSE ON THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. ACCORDING TO THE FSE, HE WAS UNABLE TO CONFIRM THE CUSTOMER'S REPORTED PROBLEM DURING HIS EVALUATION. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND WAS RETURNED TO SERVICE. A SEARCH IN SALESFORCE FOUND NO FURTHER RELATED CALLS. WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF CAUSE UNKNOWN. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S FACILITY. SUBSEQUENT TO THE RECEIPT OF THIS COMPLAINT, AN ISSUE IMPACT ASSESSMENT (IIA-2975-2022-511) WAS SUBMITTED FOR THE ISSUE REPORTED. ANY ADDITIONAL INVESTIGATION OR ACTION TAKEN WILL BE DOCUMENTED IN THE RESPECTIVE RECORD.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MONITORING SCREEN WENT BLANK AFTER SHOCKING (DEFIBRILLATING) A PATIENT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITORING SCREEN WENT BLANK AFTER SHOCKING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653418 XPERIM HARDWARE XPERIM HARDWARE MHX INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 860335 00884838084919

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other