BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP MONITOR

    MDR report key: 14989859 · Received July 12, 2022

    Report

    Report Number
    3014334038-2022-00153
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Report Date
    August 31, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780533788
    PMA / PMN Number
    K183406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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, H7, H10. CERELINK MONITOR WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    LINKED TO MFG REPORT NUMBER: 3013886523-2022-00305. A FACILITY REPORTED A CABLE FAILURE ERROR WAS DISPLAYING ON THE CERELINK MONITOR. CUSTOMER REPLACED THE YELLOW TRANSDUCER CABLE BUT WAS STILL GETTING THE MESSAGE AFTERWARDS. SALES REP GOT HIM TO REBOOT - SAME MESSAGE. REBOOT AGAIN DISCONNECTING ALL CABLES - SAME MESSAGE. TRIED VARIOUS WAYS OF REBOOTING BUT KEPT ON GETTING MESSAGE. THEY SWAPPED THE CABLE OUT AGAIN AND EVEN THE CERELINK MONITOR BUT COULDN'T RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669355 CERELINK ICP MONITOR ICP MONITOR-CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 826820 10381780533788

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown