BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENUINE GRASS REUSABLE CUP EEG ELECTRODES

    MDR report key: 21613604 · Received March 15, 2025

    Report

    Report Number
    3010611950-2025-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2025
    Date of Event
    December 1, 2024
    Report Date
    May 15, 2025
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW REPORT 001 REF NATUS COMPLAINT# (B)(4). WITH REFERENCE TO REPORT - UF/IMPORTER REPORT# (B)(4) THE FOLLOWING WAS DOCUMENTED: PATIENT HAD STAGE 2 PRESSURE INJURIES TO THE SCALP AFTER EEG. ORIGINAL INTENDED PROCEDURE WAS: LTM EEG. BRAND NAME NOTED AS: GENUINE GRASS REUSABLE CUP EEG ELECTRODES. MODEL# A010571B, LOT# 056408, PROCODE: GXY. UPON INVESTIGATION IT WAS NOTED THAT MODEL # A010571B IS NOT A NATUS PART NUMBER. AN ADVERSE EVENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER REQUESTING A PICTURE OF THE ELECTRODE LABEL AND CONFIRM AFFECTED PART#. VARIOUS FOLLOW UP ATTEMPTS WERE MADE TO THE CUSTOMER. CUSTOMER RETURNED THE COMPLETED QUESTIONNAIRE. THE CUSTOMER ADVISED THAT THEY REACHED OUT TO THE CLINICIAN FOR ASSISTANCE AND THE REPLIES ARE SOMEWHAT VAGUE. THE CUSTOMER ADVISED THAT THEY WERE DOING LTM MONITORING USING AN XLTEK EEG MACHINE, DISPOSABLE EEG ELECTRODES, NU-PREP AND 10/20 PAST, SKIN SAVERS AND TAPE. THE PROCEDURE TOOK BETWEEN 24-48 HOURS. THE CUSTOMER CONFIRMED IT'S POSSIBLE TO RETURN THE DEVICE. 13-MAY-2025: IT HAS BEEN MORE THAN 30 DAYS SINCE A FOLLOW UP WAS MADE TO THE CUSTOMER TO ASK IF PRODUCT IS AVAILABLE AND ABLE TO BE RETURNED TO NATUS FOR EVALUATION. THE CUSTOMER HAS NOT RESPONDED AND THE PART HAS NOT BEEN RECEIVED BACK. THE COMPLAINT IS CLOSED OUT WITHOUT AN AFFECTED ITEM AND WITHOUT DOING A RISK ANALYSIS. THE MODEL NUMBER PROVIDED THROUGH THE MEDSUN REPORT IS NOT COMING UP AS A VALID NATUS PART NUMBER. ATTEMPTS WERE MADE TO VERIFY THE PART NUMBER, BUT THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION WHICH WOULD BE USED TO CONFIRM THE AFFECTED ITEM PART NUMBER. THE PRODUCT LINE, CIT, AREA, AND SUB AREA WERE POPULATED, BASED ON INFORMATION RECEIVED THROUGH THE MEDSUN REPORT. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW. NO RELATED CAPAS. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT(B)(4). WITH REFERENCE TO REPORT - UF/IMPORTER REPORT# (B)(4) THE FOLLOWING WAS DOCUMENTED: PATIENT HAD STAGE 2 PRESSURE INJURIES TO THE SCALP AFTER EEG. ORIGINAL INTENDED PROCEDURE WAS : LTM EEG BRAND NAME NOTED AS: GENUINE GRASS REUSABLE CUP EEG ELECTRODES MODEL# A010571B, LOT# 056408, PROCODE: GXY. UPON INVESTIGATION IT WAS NOTED THAT MODEL # A010571B IS NOT A NATUS PART NUMBER. A ADVERSE EVENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER REQUESTING A PICTURE OF THE ELECTRODE LABEL AND CONFIRM AFFECTED PART#. VARIOUS FOLLOW UP ATTEMPTS WERE MADE TO THE CUSTOMER BUT NO RESPONSE TODATE. (B)(6) 2025: TECHNICAL SERVICE CALLED THE CUSTOMER AND LEFT A VOICEMAIL. AWAITING RESPONSE FROM THE CUSTOMER.

    Description of Event or Problem · 0

    PATIENT HAD STAGE 2 PRESSURE INJURIES TO THE SCALP AFTER EEG. THE PROCEDURE WAS LTM EEG.

    Description of Event or Problem · 0

    PATIENT HAD STAGE 2 PRESSURE INJURIES TO THE SCALP AFTER EEG. THE PROCEDURE WAS LTM EEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283238 GENUINE GRASS REUSABLE CUP EEG ELECTRODES GENUINE GRASS REUSABLE CUP EEG ELECTRODES GXY NATUS NEUROLOGY INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other