BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER INFORMATION MANAGEMENT SYSTEM PM5

    MDR report key: 4524869 · Received February 13, 2015

    Report

    Report Number
    1051786-2015-00004
    Event Type
    Death
    Date Received
    February 13, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    WITT BIOMEDICAL CORP
    Product Code
    MWI
    PMA / PMN Number
    K063840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE USER FACILITY DID NOT ASSERT THAT THE NIBP OR CARDIAC OUTPUT ISSUES CAUSED OR CONTRIBUTED TO THE PT'S DEATH, THE DEVICE MANUFACTURER IS CONTINUING TO GATHER ENOUGH INFORMATION TO CONFIRM THIS TO BE THE CASE. THEREFORE, WE ARE REPORTING THIS IN ORDER TO MEET REPORTING DEADLINES. A FINAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PHILIPS FIELD SERVICE COULD NOT DUPLICATE THE CUSTOMER REPORTED PROBLEM WHEN THE DEVICE WAS TESTED. BASED ON THE SEDATION DATA FLOW SHEET, WHICH REFLECTED INTERMITTENT NIBP AND OCCASIONAL TIMEOUTS AT THE TIME OF THE EVENT, PHILIPS FIELD SERVICE REPLACED THE NIBP MODULE (PART NUMBER 452230031122). THE NIBP MODULE THAT WAS REMOVED FROM THE DEVICE WAS EVALUATED BY PHILIPS ENGINEERING. ACCURACY OF THE RETURNED NIBP MODULE WAS CONFIRMED USING A FLUKE CUFFLINK NIBP SIMULATOR. ADDITIONALLY, THE MODULE WAS SET UP TO TAKE A READING EVERY 5 MINUTES AND RECORD THE RESULTS IN VITAL CAPTURE. THERE WERE NO FAILURES DURING THE 12 HOUR TESTING TIMEFRAME. THE CUSTOMER REPORTED PROBLEM COULD NOT BE CONFIRMED. CONSERVATIVELY, WE WILL CONSIDER THIS AS A MALFUNCTION OF INSUFFICIENT INFORMATION AND UNDETERMINED CAUSE. THERE IS NO INDICATION THAT THE DEVICE WAS USED INCORRECTLY. THE CATH LAB MANAGER (RN), REPORTED TO PHILIPS THAT, IN THE USER FACILITY¿S CLINICAL OPINION, THE ALLEGED DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. PHILIPS REQUESTED THE USER FACILITY¿S CLINICAL OPINION REGARDING THE CAUSE OF THE PATIENT¿S DEATH, BUT DID NOT RECEIVE A RESPONSE. ALSO, THE CUSTOMER DID NOT PROVIDE EXPLANATION AS TO WHY AN ALTERNATE MONITORING SOURCE WAS NOT USED AS INSTRUCTED IN DEVICE¿S INSTRUCTIONS FOR USE: SECTION 2.4.36, ALTERNATE MONITORING SOURCE: ¿THE ACC/AHA GUIDELINES FOR CARDIAC CATHETERIZATION LABS (JACC VOLUME 18, NO. 5) EMPHASIZE THE IMPORTANCE OF PATIENT MONITORING DURING CARDIAC CATHETERIZATION PROCEDURES. IN VIEW OF THIS, PHILIPS HEALTHCARE STRONGLY RECOMMENDS THAT REDUNDANT MONITORING CAPABILITIES BE AVAILABLE. THE (B)(4) SHOULD NOT BE THE SOLE MEANS OF MONITORING PATIENTS DURING CARDIAC CATHETERIZATION PROCEDURES." THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE USER FACILITY CALLED THE DEVICE MANUFACTURER FOR ASSISTANCE WITH A PROBLEM WITH CARDIAC OUTPUT. THE USER FACILITY ASKED THE DEVICE MANUFACTURER IF THEY COULD REMOTELY CONNECT TO THE DEVICE TO CHECK IT. THE DEVICE MANUFACTURER CONNECTED TO THE USER FACILITY'S DEVICE AS REQUESTED, BUT COULD NOT LOCATE THE SOURCE OF THE PROBLEM. LATER, THE USER FACILITY CALLED THE DEVICE MANUFACTURER AGAIN AND REPORTED THAT NIBP WAS NOT FUNCTIONING AND HAD NOT BEEN FOR AT LEAST THE LAST TWO CASES. THE USER FACILITY ASKED ABOUT A PENDING ON-SITE SERVICE CALL, WHICH WAS SCHEDULED AFTER THE USER FACILITY REPORTED THE INITIAL ISSUE WITH CARDIAC OUTPUT. THE USER FACILITY WAS UPSET THAT ABOUT THE TIMELINE FOR RECEIVING ON-SITE SERVICE AND INFORMED THE DEVICE MANUFACTURER THAT THE PREVIOUS PT HAD BEEN BROUGHT TO THE LAB IN ACUTE DISTRESS, ALREADY INTUBATED, AND CPR HAD TO BEGIN ALMOST IMMEDIATELY. THE USER FACILITY REPORTED THAT THE PT LATER EXPIRED. THE USER FACILITY ALSO INFORMED THE DEVICE MANUFACTURER THAT THE CASE BEFORE THAT WAS PERFORMED USING AN ALTERNATE NIBP MONITORING DEVICE. THE USER FACILITY DID NOT EXPLAIN WHY THE ALTERNATIVE DEVICE WAS NOT USED DURING THE LAST CASE. THE USER FACILITY WAS ADAMANT THAT THEY BE ABLE TO RECEIVE STEMI AND OTHER ACUTE PTS AND WAITING FOR ON-SITE SERVICE FOR THEIR CARDIAC OUTPUT AND NIBP ISSUES WAS UNACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107715 XPER INFORMATION MANAGEMENT SYSTEM PM5 PHYSIOMONITORING AND INFORMATION SYSTEM MWI WITT BIOMEDICAL CORP 452230034951 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death