BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION MRI PATIENT MONITORING SYSTEM

    MDR report key: 3733159 · Received March 27, 2014

    Report

    Report Number
    1051786-2014-00003
    Event Type
    Death
    Date Received
    March 27, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 26, 2014
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THERE IS VERY LIMITED INFO AVAILABLE REGARDING THE REPORTED INCIDENT. THE DEVICE MFR HAS ATTEMPTED TO CONTACT THE USER FACILITY ON NUMEROUS OCCASIONS, BUT THE USER FACILITY HAS NOT BEEN AVAILABLE FOR A DISCUSSION ABOUT THE ACTUAL INCIDENT. THEREFORE, WE ARE REPORTING THIS INCIDENT WITH LIMITED INFO IN ORDER TO MEET THE 30 DAY MDR DEADLINE. THE USER FACILITY'S BIOMED REPORTED THAT THERE WAS A PT INCIDENT WHILE THE DEVICE WAS BEING USED. THE BIOMED REPORTED THAT A PT CODED AND EXPIRED SHORTLY THEREAFTER. THE BIOMED ALSO REPORTED THAT THE MRI MONITOR TECH CLAIMED THAT THE DEVICE "DID NOT DO ANYTHING" DURING THE CODE. THE BIOMED STATED THAT HE WAS NOT SURE IF THE DEVICE'S DISPLAY OR DEVICE WAS ON OR OFF AT THE TIME OF THE INCIDENT OR IF THE DEVICE DID OR DID NOT ALARM DURING THE INCIDENT. THE BIOMED REQUESTED ASSISTANCE IN CHECKING THE HISTORY STORED IN THE DEVICE AND THIS WAS PROVIDED TO HIM BY THE DEVICE MFR'S TECHNICAL SUPPORT. THE BIOMED REPORTED THAT THERE WAS HISTORY STORED IN THE DEVICE FOR (B)(6) 2014 BUT NONE FOR (B)(6) 2014. THE PT INCIDENT OCCURRED ON (B)(6) 2014. THE BIOMED ALSO REPORTED THAT THE SPO2 SENSOR WAS DAMAGED AND NOT FUNCTIONAL. THE BIOMED WAS PROVIDED WITH THE PART NUMBER TO REPLACE THE SPO2 SENSOR BY TECHNICAL SUPPORT. THE BIOMED ALSO REPORTED THAT HE CHECKED THE ECG PARAMETER AND IT WORKED AS EXPECTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO USER FACILITY. PER THE FSE, THE REPORTED PROBLEM WITH THE SPO2 SENSOR WAS CONFIRMED. THE CONNECTOR END OF THE SPO2 SENSOR WAS FOUND TO BE CRACKED AND DID NOT READ PROPERLY WHEN THE FSE EVALUATED IT. IT IS NOT KNOWN HOW THE SPO2 SENSOR CONNECTOR BECAME CRACKED. THE BIOMED INFORMED THE FSE THAT YOU CAN GET IT TO WORK IF YOU MANIPULATE IT, BUT THE FSE WAS UNABLE TO GET IT TO WORK. THE HEAD NURSE IN MRI TOLD THE FSE THAT THEY DO NOT USE SPO2, BUT THE HISTORY PULLED FROM THE DEVICE SHOWS SPO2 USAGE. THE FSE ALSO FOUND THAT THE DEVICE FAILED THE NIBP LEAK TEST. PER THE FSE, THE USER FACILITY REPLACED THE NIBP PUMP TO FIX THE PROBLEM. THE USER FACILITY ADVISED THE FSE THAT NO FURTHER SERVICE IS NEEDED FOR THE DEVICE AND THAT "EVERYBODY IS HAPPY." DURING HIS VISIT, THE FSE ALSO OBTAINED THE FOLLOWING: THE BIOMED STATED THAT HE DID NOT BELIEVE ANY OF THE EMPLOYEES IN MRI HAD TRAINING ON THE DEVICE. ANALYSIS OF THE STORED HISTORY OF THE DEVICE SHOWED DATA FOR THE FOLLOWING DAYS: ON (B)(6) 2014. THERE WAS NO STORED HISTORY FOR (B)(6)2014 OR THE DAY OF THE REPORTED PT INCIDENT, (B)(6) 2014. NOTE: THE DEVICE'S HISTORY FEATURE IS A TABULAR LISTING OF A PT'S VITAL SIGNS, WHICH ARE RECORDED EACH TIME THE DEVICE TAKES AN NIBP READING. THE FACT THAT THERE IS NO HISTORY STORED IN THE DEVICE ON THE DATE OF THE REPORTED PT INCIDENT ((B)(6) 2014) MEANS THAT EITHER NIBP WAS NOT BEING MEASURED ON THIS DAY OR THE DEVICE WAS NOT IN USE. PER THE DEVICE MFR'S SALES REP THAT THE TRAINING WAS NEEDED AS A RESULT OF THIS PT INCIDENT, BUT THE USER FACILITY ASKED FOR SOME TYPE OF COMPETENCY FORM FOR THE TRAINING SHOWING WHO ATTENDED. THE DEVICE MFR IS STILL INVESTIGATING THIS REPORTED INCIDENT AND IT IS NOT KNOWN AT THIS TIME IF THE PT MONITORING ACCESSORY OR DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PT INCIDENT. A FINAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMED REPORTED THAT THERE WAS A PT INCIDENT WHILE THE DEVICE WAS BEING USED. THE BIOMED REPORT THAT A PT CODED AND EXPIRED SHORTLY THEREAFTER. THE BIOMED ALSO REPORTED THAT THE MRI MONITOR TECH CLAIMED THAT THE DEVICE "DID NOT DO ANYTHING" DURING THE CODE. THE BIOMED STATED THAT HE WAS NOT SURE IF THE DEVICE'S DISPLAY OR DEVICE WAS ON OR OFF AT THE TIME OF THE INCIDENT OR IF THE DEVICE DID OR DID NOT ALARM DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179617 INVIVO CORPORATION MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1 Death