BEUDAMED
    FDA Adverse Event Death Summary report: N

    M10 PATIENT MONITOR

    MDR report key: 1062213 · Received June 18, 2008

    Report

    Report Number
    1051786-2008-00004
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    September 21, 2007
    Report Date
    May 20, 2008
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED OR FAILED TO PERFORM AS DESIGNED AND INTENDED. THEREFORE, THE MFR AND UF HAVE AGREED THAT THERE IS NO NEED TO EVALUATE THE DEVICE. WE ARE CONSIDERING THAT A MISUNDERSTANDING OF THE ALARM SETTINGS ON THE PART OF THE HOSP NURSING STAFF RESULTED IN A DELAY IN PROVIDING THERAPY FOR THIS PT AND THIS DELAY CANNOT BE RULED OUT AS A FACTOR IN THE PT'S DEATH. ADDITIONALLY, THE AVAILABLE INFO SUGGESTS THAT THE HOSP NURSING STAFF MAY HAVE FAILED TO CHECK AND VERIFY ALARM LIMITS EACH TIME A PARAMETER WAS USED TO ENSURE THEY WERE APPROPRIATE FOR PT BEING MONITORED. NOTE ALSO THAT THE USERS HAD THE INCORRECT IFU FOR THE MONITOR (SEE BELOW). DURING THE INVESTIGATION, THE USER STATED THAT THEY FELT THE TRAINING REC'D WHEN THE SYS WAS INITIALLY INSTALLED WAS AN "OVERVIEW ONLY" WITH NO SPECIFIC INSTRUCTIONS ON HOW TO CONFIGURE THE POWER UP DEFAULT SETTINGS. HOWEVER, REVIEW OF THE POWER UP DEFAULT SETTINGS OF THE UF'S BEDSIDE MONITORS SHOWED THAT ALL BEDSIDE MONITORS WERE NOT SET TO FACTORY DEFAULT SETTINGS AS ORIGINALLY INDICATED BY THE UF FOLLOWING THE PT EVENT. THIS WOULD INDICATE THAT THE DEFAULT SETTINGS WERE BEING CHANGED BY HOSP'S STAFF. DURING THE INVESTIGATION, IT WAS FOUND THAT THE USER POSSESSED THE INCORRECT OPERATIONS MANUAL FOR THEIR MODEL NUMBER OF BESIDE MONITOR. THE BILL OF MATERIALS FOR THE SHIPMENT TO THE CUSTOMER WAS ORDERED AND THE CORRECT MANUAL WAS RECORDED AS SHIPPED. HOWEVER, THE CUSTOMER CLAIMS THE INCORRECT MANUAL WAS RECORDED AS SHIPPED. HOWEVER, THE CUSTOMER CLAIMS THE INCORRECT MANUAL WAS RECEIVED BY THEM. THE MFR REVIEWED ALL RECORDS AND FOUND THAT THERE WERE NO REPORTS MADE THAT THE UF REC'D AN INCORRECT OPERATIONS MANUAL. ADDITIONALLY, THERE HAVE BEEN NO REQUESTS BY THIS UF FOR ADD'L TRAINING ON THE MONITORING SYS IN THE TWO YRS OF MONITORING SINCE THE INSTALLATION. ONLY AFTER THE OCCURRENCE OF THIS PT EVENT WERE THESE PROBLEMS REPORTED TO THE MFR. UPON INSTALLATION OF BESIDE MONITORS AND CENTRAL STATION SYS, USERS ARE ROUTINELY PROVIDED WITH OPERATIONS MANUALS, QUICK REFERENCE GUIDES AND IN-SVC TRAINING CONDUCTED BY A CLINICAL APPLICATIONS SPECIALIST. DURING IN-SVC TRAINING, CHECKLISTS AND IN-SVC GUIDES ARE UTILIZED BY THE CLINICAL APPLICATIONS SPECIALIST TO ENSURE THAT ALL IMPORTANT POINTS ARE CONSISTENTLY COVERED WITH EACH USER BEING TRAINED. A REVIEW OF THE CHECKLISTS AND IN-SVC GUIDES UTILIZED IN INITIAL USER TRAINING SHOWED THAT THE TRAINING ADEQUATELY COVERS THE SETTING OF ALARMS AND POTENTIAL ALARM ISSUES, INCLUDING: ALARM SUSPENDED FEATURE, TAILORING PT ALARMS TO FIT THE CLINICAL SCENARIO, THE EFFECTS OF TURNING OFF ALARMS AT THE CENTRAL STATION VS. BEDSIDE, AND THE SYMBOLS DISPLAYED BY THE MONITORING SYS WHEN ALARMS ARE ON (BELL) VS. OFF (BELL WITH "X" THROUGH IT). FINALLY FOLLOWING INITIAL INSTALLATION AND IN-SVC TRAINING, USERS HAVE ACCESS TO THE MFR'S TECHNICAL SUPPORT STAFF, WHICH IS AVAILABLE 24 HRS A DAY TO GET ADD'L INFO OR REPORT ANY PROBLEMS WITH THE MONITORING SYS. AT THE REQUEST OF THIS UF, THE MFR HAS PROVIDED FIVE ADD'L IN-SVC TRAINING CLASSES FOR THE UF STAFF. THE CLASSES INCLUDED STAFF FROM BOTH DAY AND NIGHT SHIFT AND EACH SESSION INCLUDED TRAINING WITH REGARDS TO OPERATION OF THE MONITOR: TRACE SELECTION, A DESCRIPTION OF EACH ALARM, STEP BY STEP INSTRUCTIONS FOR USE FOR EACH PARAMETER AND CONFIGURATION FOR POWER UP DEFAULT SETTINGS. FOLLOWING THIS TRAINING, THE UF STATE THAT THEY WERE SATISFIED WITH THE LEVEL OF TRAINING THAT WAS PROVIDED DURING THIS SITE VISIT AND STATED THAT THIS TRAINING MET THEIR NEEDS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE USER FACILITY (UF) THAT THE UF WAS HAVING PROBLEMS WITH ALARMS AND NEEDED IN-SVC TRAINING ON THE SYS. AFTER FURTHER EVAL, IT WAS DISCLOSED BY THE UF THAT A PT HAD CODED AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M10 PATIENT MONITOR PATIENT MONITOR, VITAL SIGNS MONITOR MHX INVIVO CORPORATION 20415

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death