BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 7086065 · Received December 6, 2017

    Report

    Report Number
    1051786-2017-00016
    Event Type
    Death
    Date Received
    December 6, 2017
    Report Date
    November 7, 2017
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT WAS GIVEN ¿SOME SEDATION¿ BY A NURSE AND THE NURSE LEFT. THE EMPLOYEE RELAYING THIS INFORMATION TO THE CLINICAL PRODUCT SPECIALIST (CPS) DIDN¿T KNOW SPECIFICALLY WHAT MEDICATION THE PATIENT WAS GIVEN. ACCORDING TO THE EMPLOYEE, THE PATIENT WAS NOT CONNECTED TO THEIR EXPRESSION PATIENT MONITORING DEVICE DURING THE SCAN AND THE PATIENT PASSED AWAY. ACCORDING TO THE CPS, THERE WAS NO ALLEGATION MADE WITH REGARDS TO THE PATIENT MONITOR, SINCE THE PATIENT MONITOR WAS NOT IN USE DURING THE CASE. DURING THE SITE VISIT, THE CPS IDENTIFIED MANY FAILURES TO USE THE DEVICE AS INSTRUCTED IN THE IFU, SUCH AS USE OF NON-APPROVED ELECTRODES, NOT PREPPING PATIENTS PROPERLY AND IMPROPER ELECTRODE PLACEMENT. IN ADDITION, THE USERS HAD AN SPO2 CABLE THAT NEEDED TO BE REPLACED, WHICH WAS CAUSING ISSUES WITH MONITORING SPO2. IT IS UNKNOWN AT THIS TIME IF THE PATIENT MONITOR WAS NOT IN USE BECAUSE USERS FELT THAT IT WAS NOT WORKING PROPERLY OR THAT THERE WAS A CONSCIOUS DECISION TO NOT USE THE PATIENT MONITOR WITH THIS PATIENT. THEREFORE, WE ARE REPORTING THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE DEVICE AND PATIENT HAVE BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE WAS NOT PERFORMED. PHILIPS MADE MULTIPLE ATTEMPTS (6 TOTAL; 4 IN WRITING AND 2 VIA TELEPHONE) TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS REPORTED PATIENT DEATH . NONE OF THESE ATTEMPTS RESULTED IN ANY ADDITIONAL INFORMATION. IT WAS REPORTED THAT A FEMALE PATIENT PASSED AWAY DURING AN MRI EXAMINATION AND THAT THE DEVICE WAS NOT BEING USED TO MONITOR THE PATIENT DURING THE CASE. IT IS UNKNOWN IF THE PATIENT MONITOR WAS NOT IN USE BECAUSE USERS FELT THAT IT WAS NOT WORKING PROPERLY OR THAT THERE WAS A CONSCIOUS DECISION TO NOT USE THE PATIENT MONITOR WITH THIS PATIENT. DURING A RECENT SITE VISIT, THE CPS IDENTIFIED MANY FAILURES TO USE THE DEVICE AS INSTRUCTED IN THE IFU, SUCH AS USE OF NON-APPROVED ELECTRODES, NOT PREPPING PATIENTS PROPERLY AND IMPROPER ELECTRODE PLACEMENT. IN ADDITION, THE USERS HAD A SPO2 CABLE THAT NEEDED TO BE REPLACED, WHICH WAS CAUSING ISSUES WITH MONITORING SPO2. REVIEW OF ONEEMS FOR CASES RELATED TO EACH MONITORING COMPONENT WAS PERFORMED AND NONE OF THE CASES THAT HAVE BEEN OPENED REPORTED A PATIENT DEATH. THE INVESTIGATOR IS CLOSING THIS COMPLAINT UNDER GOOD FAITH EFFORT MADE, BUT THE COMPLAINT CAN BE REOPENED UPON RECEIPT OF ADDITIONAL INFORMATION. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    DURING A SITE VISIT FOR ADDITIONAL TRAINING, THE CLINICAL PRODUCT SPECIALIST (CPS) WAS TOLD THAT, APPROXIMATELY 3 MONTHS PRIOR TO HER VISIT, THERE WAS A FEMALE PATIENT WHO HAS A HISTORY OF SLEEP APNEA THAT UNDERWENT AN MRI IN A PHILIPS MAGNET.. IT WAS REPORTED THAT THE FEMALE PATIENT PASSED AWAY DURING AN MRI EXAMINATION AND THAT THE DEVICE WAS NOT BEING USED TO MONITOR THE PATIENT DURING THE CASE.

    Description of Event or Problem · 1

    DURING A SITE VISIT FOR ADDITIONAL TRAINING, THE CLINICAL PRODUCT SPECIALIST (CPS) WAS TOLD THAT, APPROXIMATELY 3 MONTHS PRIOR TO HER VISIT, THERE WAS A FEMALE PATIENT WHO HAS A HISTORY OF SLEEP APNEA THAT UNDERWENT AN MRI IN A PHILIPS MAGNET. IT WAS REPORTED THAT THE FEMALE PATIENT PASSED AWAY DURING AN MRI EXAMINATION AND THAT THE DEVICE WAS NOT BEING USED TO MONITOR THE PATIENT DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868290 INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1 Death