BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP MONITOR

    MDR report key: 18383947 · Received December 22, 2023

    Report

    Report Number
    3014334038-2023-00195
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Report Date
    July 12, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10886704075622
    PMA / PMN Number
    K183406
    Removal / Correction Number
    3014334038-10/05/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE CERELINK MONITOR (ID (B)(4) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, THE CUSTOMER REPORTED THAT THEY DID NOT FEEL A NEED TO CONTINUE PURSUING AN INVESTIGATION AS THEY BELIEVE THERE MAY HAVE BEEN USER ERROR CAUSING THE ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B5, D8, D9, G1, G3, G6, H1, H2, H3, H9. FOLLOW-UP SUBMITTED TO INCLUDE "CORRECTION/REMOVAL RPT NUMBER" (3014334038-10/05/2023-002-R) (H9).

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERELINK MONITOR ((B)(6). ) SHOWING OUT OF RANGE VALUES AND CONTINUED TO OCCUR AFTER CHANGING THE CABLES, POWER SUPPLY AND MOVING IT AWAY FROM OTHER DEVICES. OVER THE WEEKEND, THE VALUE BECAME NEGATIVE (-4). TROUBLESHOOTING WAS DONE BY ELECTROCARDIOGRAM (ECG) LEAD CHANGED, MACHINE PLUGGED INTO WALL AND KEEPING IT AWAY FROM OTHER DEVICES HOWEVER, IT WAS NOT RESOLVED. EVENTUALLY THE NUMBERS BECAME POSITIVE BUT WIDE SWINGS IN THE VALUES 2-30, WITH THE LOW VALUES NOT IN LINE WITH THE IMAGING AND CLINICAL ACTIVITIES. NO PATIENT INJURY REPORTED. CUSTOMER STATED THAT IT MAY HAVE BEEN USER ERROR. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309076 CERELINK ICP MONITOR ICP MONITOR-CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 10886704075622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown