BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 2887568 · Received December 19, 2012

    Report

    Report Number
    MW5028299
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 19, 2012
    Manufacturer
    WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA IN
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOWNTIME ON (B)(6) 2012. PHILIPS XPER FLEXCARDIO CATH LAB MONITORING SYSTEM IMPLEMENTED ON (B)(6) 2012. ON THE MORNING OF (B)(6) 2012, MONITORING IN 3 CARDIAC CATHETERIZATION ROOMS DID NOT FUNCTION CORRECTLY. AS A RESULT SEVERAL PT PROCEDURE WERE POSTPONED. PHILIPS REMOTELY RE-INSTALLED THE SOFTWARE TO THE COMPUTERS AND MONITORS AND LATER ALTERED CERTAIN SYSTEM SETTINGS IN AN ATTEMPT TO ADDRESS THE OCCURRENCE. MULTIPLE SERIAL NUMBERS XPER HOST PC'S DELL. DATES: (B)(6) 2012 TO PRESENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR (B)(4) 2013: ON (B)(6) 2012, A PHILIPS CUSTOMER SUPPORT REP SPOKE WITH A HOSPITAL CLINICAL STAFF MEMBER WHO REPORTED THEY TRIED TO LAUNCH SOFTWARE AND COULD NOT GET ANY MONITORING, IN ADDITION TO THEIR 2ND MONITOR SCREEN WAS "BLUE" WITH NO DISPLAY OF A CASE. THE CUSTOMER SUPPORT REP DIALED INTO THE CUSTOMER'S SYSTEM AND FOUND THAT THE FLEX CARDIO FILES THAT INTERACT WITH THE XPER IM SOFTWARE HAD BEEN UNINSTALLED. A PHILIPS TECHNICAL SUPPORT ENGINEER THEN ASSISTED THE CUSTOMER WITH INSTALLING THE SOFTWARE TO ALLOW MONITORING. THE CUSTOMER'S SOFTWARE HAD BEEN UPGRADED THREE DAYS PRIOR TO THIS ISSUE BEING REPORTED. IT WAS DETERMINED THAT THE UPGRADED XPER IM SOFTWARE FOR WORKSTATIONS HAD NOT BEEN INSTALLED ON THIS SYSTEM WHERE THIS ISSUE HAD BEEN REPORTED. ONCE THE SOFTWARE WAS INSTALLED ALONG WITH THE ON THE WORKSTATION IN ADDITION TO ADDING THE NECESSARY FLEX CARDIO FILES, THE SYSTEM FUNCTIONED AS INTENDED. ADDITIONALLY, FIELD SERVICE PERSONNEL WAS ALSO DISPATCHED TO THE CUSTOMER SITE TO REVIEW THE MONITOR APPEARING "BLUE" WITH NO DISPLAY OF A CASE. FIELD SERVICE PERSONNEL REPLACED THE MONITOR TO RESOLVE THIS ISSUE. THE MONITOR WAS NOT RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT AS NO PT WAS INVOLVED. MEDICAL PROFESSIONALS WILL IDENTIFY THE PROBLEM AND WILL EITHER POSTPONE PROCEDURES OR UTILIZE ALTERNATE MONITORING EQUIPMENT (WHICH IS SPECIFIED/RECOMMENDED IN OUR LABELING); 510K: K5101571. DEVICE MFR DATE: 06/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM CATH LAB MONITORS DRT WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA IN 453564243621 NA
    2 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    3 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    4 PHILIPS XPER CARDIAC MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    5 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    6 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    7 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA
    8 PHILIPS XPER CARDIAC CATH MONITORING SYSTEM CATH LAB MONITORS DRT PHILIPS FC2010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening