BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.

    MDR report key: 6925819 · Received October 6, 2017

    Report

    Report Number
    9612007-2017-00028
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 14, 2017
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 10/31/2017. THE DEVICE HISTORY RECORDS REVIEW OF REF (B)(4), LOT 0200589, SN (B)(4) INCLUDING CC1P1/VK52 DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN MARCH 2017. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. A REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE SINCE 2014 FOR CC1P1 AND RELATED KITS (IT2, IT2EU, IP1P, IP2P) REVEALED NO ADVERSE TREND. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL (THE PROBE PLACEMENT WAS CONFIRMED TO BE CORRECT) BUT DID NOT ALLOW TO DETERMINE THE EXACT ROOT CAUSE OF THE UNSTABLE OXYGEN VALUES. SINCE NO PRODUCT WAS RECEIVED, THE COMPLAINT IS UNVERIFIABLE. THE AVAILABLE INFORMATION DID NOT ALLOW US TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    AN ISSUE WITH THE VALUE WAS REPORTED. THE PATIENT HAD TUNNELED CATHETER WITH COMBINED PROBE. THIS HAPPENED DURING TREATMENT. WAVY / FLOWING/SCROLLING CURVE WAS DISPLAYED ON THE PATIENT'S BEDSIDE MONITOR. THIS IS THE THIRD INCIDENT. THE PATIENT WAS NOT INJURED. THE EVENT DID NOT LEAD TO LATE MONITORING OF THE PATIENT. THE MEDICAL STAFF TRUSTED THE MEASUREMENT, BECAUSE THEY COULD SEE THAT THEY HAD AN RESPONSE ON THE VALUE WHEN THEY CHANGED THE OXYGEN PRESSURE. A LICOX MONITOR (LCX02, SERIAL NUMBER: (B)(4)) WAS ALSO USED. THE USER IS ACCUSTOMED TO USING THE DEVICE AND ALSO THE MONITOR. THE USER DID NOT NOTE ANY DAMAGE ON THE PROBE DURING THE FOLLOWING: AFTER THE PROTECTIVE TUBE WAS REMOVED; AFTER THE INSERTION OF THE PROBE INTO THE TUNNELING CATHETER AND JUST BEFORE INSERTION OF THE DISTAL END OF THE PROBE INTO THE BRAIN; AFTER REMOVAL OF THE PROBE AT THE END OF THE MONITORING. AFTER THE PROBE INSERTION THROUGH TUNNELING CATHETER, THE USER CHECKED THE PLACEMENT OF THE PROBE BY X-RAY. PROBE PLACEMENT WAS NOT RE-CHECKED WHEN THE VALUES STARTED TO FLUCTUATE BUT IT WAS REPORTED THAT PATIENTS GO TO X-RAY SEVERAL TIMES AND NOTHING WAS NOTICED ABOUT THE PLACEMENT OF THE PROBE. THE CUSTOMER IS A FREQUENT USER OF THE DEVICE DID NOT NOTICE BAD/WRONG PLACEMENT. THE USER PERFORMED THE SYNCHRONIZATION OF THE TWO MONITORS (LCX02 MONITOR AND BEDSIDE MONITOR) ACCORDING TO USER MANUAL OF LCX02 MONITOR. THE SYNCHRONIZATION OF THE TWO MONITORS WAS DONE FOR EACH OF THE FOLLOWING SITUATIONS: FIRST TIME THAT THE INTEGRA LICOX PTO2 MONITOR WAS CONNECTED TO A PATIENT BEDSIDE MONITOR; IF THE INTEGRA LICOX PTO2 MONITOR WAS DISCONNECTED FROM A PATIENT BEDSIDE MONITOR (E.G. DUE TO PATIENT TRANSPORT TO CT OR OR), AND THEN NEEDED TO BE RE-CONNECTED; IF DURING USE, THE REPORTED PTO2 VALUES BETWEEN THE INTEGRA LICOX PTO2 MONITOR AND THE PATIENT BEDSIDE MONITOR EXCEEDS THE STATED ACCURACY RANGE. LINKED TO MFG. REPORT NUMBERS: 9612007-2017-00024 AND 9612007-2017-00025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705560 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 0200589

    Patients

    Seq Age Sex Outcome Treatment
    1