BEUDAMED
    FDA Adverse Event Other Summary report: N

    XPERFLEX CARDIO PHYSIOMONITORING SYSTEM FC2010

    MDR report key: 2593895 · Received May 24, 2012

    Report

    Report Number
    1039368-2012-00001
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 24, 2012
    Manufacturer
    WITT BIOMEDICAL CORP., A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA INC.
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHILIPS CLINICAL SUPPORT ENGINEER SPOKE AT LENGTH WITH THE HOSPITAL CLINICAL STAFF MEMBER WHO WAS REPORTING THE EVENT. THE 'FULL DISCLOSURE' FILE AND SNAP SHOTS OF THE CASE WERE REMOTELY DOWNLOADED FROM THE CONNECTED WORKSTATION AND REVIEWED. THE 'FLAT LINE' EVENT WAS SEEN AT APPROXIMATELY 8:55AM IN THE FULL DISCLOSURE FILE. UPON REVIEW, IT IS EVENT THAT THE PATIENT'S ECG WAVEFORM WAS PRESENT, BUT THAT THERE WAS A MARKED DECREASE IN AMPLITUDE OF THE SIGNAL. LEADS II AND VI WERE DISPLAYED ON SCREEN AT 100 GAIN. THERE WAS CLEAR EVIDENCE OF ECG ACTIVITY ALBEIT REMARKABLY DIFFERENT THAN WHAT HAD BEEN SEEN EARLIER IN THE CASE. THERE WAS A CLEARLY VISIBLE SPO2 WAVEFORM THAT SHOWED THE HEART RATE TO BE IN THE 70'S AND THE OXYGEN SATURATION TO BE 99 PERCENT. UPON POST EVENT REVIEW, ANALYSIS AND DISCUSSION, THE STAFF MEMBER BELIEVES THAT THE ECG MONITORING PARAMETER WAS FUNCTIONING APPROPRIATELY AND THAT THE EQUIPMENT WAS NOT THE CAUSE OF THE STAFF'S DECISION TO BEGIN CHEST COMPRESSIONS. THE CLINICAL STAFF BELIEVED THAT THE DECREASE IN ECG AMPLITUDE WAS MOST LIKELY RELATED TO LOW VOLTAGE ECG THAT WAS RELATED TO THE PROCEDURE THAT WAS UNNECESSARY. THE PATIENT WAS NOT HARMED. INVESTIGATION SHOWED THAT DEVICE FUNCTIONED AS INTENDED. EVALUATION OF IFU INDICATED THAT IFU IS ADEQUATE IN THAT IT INFORMS THE USER THAT "ITS USERS, RESPONSIBLE TO INTERPRET THE DATA MADE AVAILABLE, WILL BE PROFESSIONAL HEALTH CARE PROVIDERS, SUCH AS PHYSICIANS, REGISTERED NURSES, CARDIOVASCULAR TECHNICIANS, RADIOLOGY TECHNICIANS, AND OTHER CLINICAL HEALTH CARE PROVIDERS." IT ALSO INFORMS USER THAT "LIKEWISE, PATIENT DIAGNOSIS SHOULD NOT BE BASED SOLELY ON RESULTS PROVIDED BY XPER FLEX CARDIO PHYSIOMONITORING SYSTEM."

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE CUSTOMER CONTACTED PHILIPS TECHNICAL SUPPORT AND REPORTED THAT THE ECG WENT FLATLINE DURING PACEMAKER IMPLANTATION. JUST AS THE GENERATOR WAS PUT IN THE POCKET THE ECG SHOWED SOME ARTIFACT WAS MOSTLY FLATLINE. SPO2 WAVEFORM SHOWED A NORMAL WAVEFORM. THE STAFF SAW AN 8 SECOND EPISODE OF FLATLINE AND THEY DID START TO PERFORM CPR UNTIL THE PATIENT SHOWED ACTIVITY. CONTINUED INVESTIGATION WITH THE ACCOUNT INDICATED THAT AT THE MOMENT THE ECG WENT DOWN IN SIZE THEY WERE CHANGING IT OVER FROM THE EXTERNAL GENERATOR TO THE INTERNAL AND WAS SCREWING THE LEADS IN. THIS COULD ACCOUNT FOR THE DIMINISHED GAIN IN THE ECG AND IT WAS STILL BEING CAPTURED BY THE HEART RATE EVENT THOUGH THE EXTERNAL ECG LEADS READ IT AS VERY LOW VOLTAGE. THE CPR WAS PERFORMED FOR A SECOND OR TWO UNTIL THE PATIENT SPOKE TO THEM. AFTER REVIEWING THE ECG AND SPO2 PULSE OX WAVEFORM AT THE TIME OF THE SUSPECTED FLATLINE THE STAFF AGREED THAT THE LOW VOLTAGE ECG WAS IN FACT THE PATIENT'S ECG AND THE CPR WAS UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERFLEX CARDIO PHYSIOMONITORING SYSTEM FC2010 PHYSIOMONITORING SYSTEM MWI WITT BIOMEDICAL CORP., A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA INC. 453564243591

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other