BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 14753997 · Received June 21, 2022

    Report

    Report Number
    3013886523-2022-00278
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    April 14, 2022
    Report Date
    September 20, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520689
    PMA / PMN Number
    K173192
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10 THE CERELINK MICROSENSOR WAS RETURNED FOR EVALUATION: DHR - THE LOT MET SPECIFICATIONS WHEN RELEASED FAILURE ANALYSIS - NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL, OR CONNECTOR. CERELINK MONITOR READING WAS ACCEPTABLE; ICP EXPRESS READING 512. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TEST. ROOT CAUSE - THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE TO INAPPROPRIATE TECHNIQUE FOR ASSEMBLY AND USE OF THE DEVICE.

    Description of Event or Problem · 0

    3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00276, 3013886523-2022-00277. A FACILITY REPORTED WHEN CONNECTING THE DIRECTLINK FOR PIC MEASUREMENT THE LIGHT DOES NOT TURN GREEN (STAYS ORANGE). MEDICAL STAFF TRIED CHANGING BOTH MONITORS AND DIRECRLINKS, BUT THE PROBLEM REMAINED. ON THE FOURTH SENSOR, THE SYSTEM WORKED PROPERLY. THE PATIENT WAS NOT MONITORED FOR 1 HOUR. RELEVANT ANSWERS TO CLINICAL QUESTIONNAIRE: DID THE FAILURE OCCUR DURING PATIENT MOVEMENT? (I.E. REPOSITION, TRANSPORT, OUT OF BED FOR BATHROOM, AMBULATE, CHAIR, ETC.) BEFORE. DID THE PATIENT RECEIVE AN MRI OR CT SCAN BEFORE THE FAILURE OCCURRED? CT SCAN. WHAT WAS THE MEAN ICP BEFORE THE ¿EVENT?¿ ICP VALUE: NA. WHAT WAS THE ICP WAVEFORM QUALITY BEFORE THE ¿EVENT?¿ (IF CONNECTED TO PATIENT MONITOR) THE PROBLEM STARTED BEFORE THE ICP MEASUREMENT. WHAT IS THE ICP WAVEFORM QUALITY AFTER THE ¿EVENT?¿ OVER THE LIMITS. WHEN THE FAILURE OCCURRED, WAS THE INTEGRA/CODMAN ICP MONITOR PLUGGED INTO THE WALL? YES. WHEN THE FAILURE OCCURRED, WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR? YES . IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL - MODEL: PHILIPS. OES THE ICP VALUE ON THE INTEGRA/CODMAN ICP MONITOR MATCH THE ICP VALUE ON THE PATIENT MONITOR? THE PROBLEM STARTED BEFORE THE ICP MEASUREMENT. WHEN THE FAILURE OCCURRED, WHERE WAS THE INTEGRA/CODMAN ICP MONITOR POSITIONED? BED. PROVIDE A DESCRIPTION OF ANY UNUSUAL EVENTS OR ISSUES THAT OCCURRED DURING THE IMPLANTATION OR DURING THE PATIENT CARE, NONE. DESCRIBE THE QUALITY OF THE INSERTION: CATHETER AND PERFORATOR DRILL.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141172 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 826851 5007652 10381780520689

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown