BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 10610758 · Received September 30, 2020

    Report

    Report Number
    3013886523-2020-00140
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 15, 2020
    Report Date
    March 24, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D10, G4, G7,H2, H3, H4, H6, H10. UNIQUE DEVICE IDENTIFIER: (B)(4). THE NEUROMONITOR BASIC KIT WAS NOT RETURNED FOR EVALUATION (DEVICE NOT RETURNED YET - NO SHIPPING INFORMATION PROVIDED) 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.

    Additional Manufacturer Narrative · 0

    THE PERFORATOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 4170957, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - COMPLAINT HAS BEEN CONFIRMED. NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL OR CONNECTOR. THE ICP EXPRESS FAILED, ZEROING ERROR. THE MILLAR SENSOR COULD NOT BE ZEROED UPON RECEIPT; TRIED TO ADJUST BALANCE AND STILL COULD NOT BE ZEROED; SENSOR OHMS ARE SPEC. THE CAUSE OF THE PROBLEM STATED TO BE USE RELATED, THE SENSOR OHMS ARE IN SPEC, BUT THE BALANCE CANNOT BE ADJSUTED. THIS ANOMALY COULD POSSIBLY BE ATTRIBUTED TO ESD (ELECTROSTATIC DISCHARGE) EXPOSURE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE MICROSENSOR COULD NOT BE ZEROED. THE EVENT OCCURRED BEFORE THE PROCEDURE, THE PHYSICIAN CHANGED WITH ANOTHER OF THE SAME DEVICE WHICH COULD BE ZEROED NORMALLY. NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071446 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 4170957

    Patients

    Seq Age Sex Outcome Treatment
    1