BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 5538018 · Received March 31, 2016

    Report

    Report Number
    1051786-2016-00007
    Event Type
    Death
    Date Received
    March 31, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 17, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN CLINICAL USE FOR PATIENT MONITORING AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. THE CUSTOMER REPORTED THAT THE PATIENT WAS HAVING A PACEMAKER PROCEDURE PERFORMED AND DURING THE PROCEDURE THE SYSTEM DISPLAYED THE ¿WRONG¿ VALUES. THE CUSTOMER CLAIMS THAT, BECAUSE OF THIS REPORTED ISSUE, THEY DID NOT ASSIST THE PATIENT IN TIME AND THE PATIENT SUBSEQUENTLY DIED. THE CUSTOMER REPORTED THAT THE SPO2, HEART RATE AND BLOOD PRESSURES THE SYSTEM DISPLAYED WERE VALUES FROM A ¿NON-DYING¿ PERSON AND THAT THIS REPORTEDLY CAUSED THE SURGEONS TO NOT PROVIDE PROPER MEDICAL SUPPORT TO THE PATIENT. THE PATIENT REPORTEDLY SUFFERED RESPIRATORY SHOCK AND PASSED AWAY. PATIENT WAS MALE, (B)(6) WITH A PRE-EXISTING CARDIAC ISSUE OF EPOC (CHRONIC OBSTRUCTIVE PULMONARY DISEASE). CUSTOMER REPORTED THAT VASOACTIVE DRUGS WERE ADMINISTERED AND THAT THE PATIENT WAS ASSISTED BY TWO CERTIFIED CARDIOLOGISTS, AN EXPERIENCED ANESTHETIST AND THE INTERNATIONAL CARDIOVASCULAR RESUSCITATION GUIDANCE WAS FOLLOWED. AN ONSITE FIELD SERVICE ENGINEER EVALUATION OF THE DEVICE COULD NOT DUPLICATE THE REPORTED PROBLEM. DURING THE INTERNAL R&D EVALUATION OF THE RETURNED DEVICE, ALL PARAMETERS WERE FOUND TO BE FUNCTIONING CORRECTLY. CLINICAL REVIEW OF THE LOG FILES, PROCEDURE HISTORY AND PICTURES PROVIDED BY THE FSE CONCLUDED THAT THERE WAS NO EVIDENCE OF AN EQUIPMENT FAILURE OR ABNORMALITY THAT WOULD PREVENT THE RECOGNITION OF THE PATIENT¿S DISTRESS. THE FULL DISCLOSURE PLAYBACK WAS FOUND TO BE CONSISTENT WITH A VERY SICK ELDERLY PATIENT UNDERGOING A PROCEDURE IN THE CATH LAB DURING WHICH TIME THE PATIENT¿S CONDITION DETERIORATED AND SUBSEQUENTLY PASSED. EVEN THOUGH A DEVICE MALFUNCTION COULD NOT BE CONFIRMED, THIS WILL BE CONSIDERED AS A MALFUNCTION OF CAUSE UNKNOWN FOR REPORTING PURPOSES ONLY. THE CUSTOMER REPLACED THE FLEX CARDIO 2010 DEVICE WITH A SPARE UNIT. THERE WERE NO FURTHER RELATED CALLS FOR THIS CUSTOMER, SUPPORTING THAT THE PROBLEM HAS NOT RECURRED. THE DEVICE THAT WAS RETURNED TO PHILIPS FOR EVALUATION WILL BE RETURNED TO THE PHILIPS SERVICE STOCK.

    Additional Manufacturer Narrative · 1

    THE DEVICE THAT WAS RETURNED TO PHILIPS FOR EVALUATION WASN NOT RETURNED TO THE CUSTOMER AND HAS NOT BEEN RETURNED TO STOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE WRONG VALUES (BLOOD PRESSURE, SPO2 & HEART RATE) WERE DISPLAYING ON THE MONITOR AND STAFF COULD NOT GIVE THE PATIENT THE PROPER MEDICAL ATTENTION REQUIRED. THE CUSTOMER REPORTS THAT SINCE THE XPER FLEX CARDIO MONITORS THE SIGNALS OF THE PATIENT, THE LIFE OF THE PATIENT COULD HAVE BEEN COMPROMISED INDIRECTLY. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193017 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM CARDIOVASCULAR MONITOR MWI INVIVO CORPORATION 453564483321

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death