BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER IM PHYSIOMONITORING 5 HOST

    MDR report key: 4046809 · Received June 6, 2014

    Report

    Report Number
    1039368-2014-00002
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Manufacturer
    WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC.
    Product Code
    DQK
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED ON (B)(6) 2013 BY (B)(6), SYSTEM ADMINISTRATOR FOR (B)(6) THEY WERE HAVING AN ISSUE WITH HAVING INACCURATE HEMODYNAMIC DATA. PHILIPS SUPPORT PERSONNEL FOUND THE ISSUE THEY WERE HAVING WAS WITH THE HEMODYNAMIC CONDITION LIST. IF THERE IS A SPACE AT THE END OF THE CONDITION THE CONDITION WILL DUPLICATE THEN RENAME THE SECOND CONDITION TO THE FIRST CONDITION IN THE LIST. PHILIPS SUPPORT PERSONNEL FOUND THE ISSUE THE ACCOUNT WAS HAVING WAS WITH THE HEMODYNAMIC CONDITION LIST. IF THERE IS A SPACE AT THE END OF THE CONDITION, THE CONDITION WILL DUPLICATE AND THEN RENAME THE SECOND CONDITION TO THE FIRST CONDITION IN THE LIST. PHILIPS SUPPORT PERSONNEL WERE ABLE TO ASSIST THE ACCOUNT TO TROUBLESHOOT THE REPORTED ISSUE AND RESOLVE IT BY REMOVING THE SPACES AT THE END OF THE CONDITION NAME. THE ACCOUNT HAS NOT CONTACTED PHILIPS WITH ANY FURTHER ISSUES WITH THE CONDITIONS LIST AFTER CUSTOMER ASSISTANCE WAS PROVIDED. PER THE REVIEW OF THE XPER INFORMATION MANAGEMENT SYSTEM PM 5 INSTRUCTIONS FOR USE RELEASE 4 (PART NUMBER PHILIPS HEALTHCARE 9896 060 00014 IPC P/N NMANXIM-ENG XPER IM PM5 MANUAL) THE CONDITION LIST IS CUSTOMIZABLE BY THE ACCOUNT AND IS A DATA ENTRY FIELD WHICH ALLOWS THE USER TO ADD SPACES. CONCLUSION: AS THIS CONDITION LIST IS CUSTOMIZABLE BY THE CUSTOMER(S) TO ADDRESS THE DIFFERENT NEEDS AT DIFFERENT ACCOUNTS, ENTRY ERRORS CAN OCCUR DURING THE GENERATION OF THAT LIST. CUSTOMER SERVICE PERSONNEL IS AVAILABLE TO ASSIST THE CUSTOMER(S) IN GENERATING THOSE LISTS; IN ADDITION PHILIPS HEALTHCARE PROVIDES USER TRAINING TO ACCOUNT REPRESENTATIVES AS NEEDED. THE REPORTED DEVICE REMAINS AT THE CUSTOMER SITE AND REMAINS IN CLINICAL USE AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    REFERENCE U/F (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333310 XPER IM PHYSIOMONITORING 5 HOST PHYSIO-MONITORING SYSTEM DQK WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC. 4522 300 34961

    Patients

    Seq Age Sex Outcome Treatment
    1