BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASS ELECTRODES

    MDR report key: 6126496 · Received November 23, 2016

    Report

    Report Number
    3005581270-2016-00007
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 27, 2016
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXY
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR (4) GRASS ELECTRODES WERE RETURNED FOR INVESTIGATION. NO VISUAL DEFECTS NOTED ON INSPECTION. NO ISSUES WITH THE PRODUCTION OF THIS LOT OF ELECTRODES. THE DEVICES WERE FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. BASED UPON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN WHETHER PATIENT FACTORS OR CLEANING PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. CUSTOMER HAS BEEN CONTACTED ON NUMEROUS OCCASIONS TO PROVIDE THE REQUIRED INFORMATION. THE FEEDBACK RECEIVED IN RELATION TO THE BELOW INFORMATION WAS MARKED AS NOT APPLICABLE. PATIENT IDENTIFIER, AGE AT THE TIME OF EVENT, DATE OF BIRTH, WEIGHT, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.), CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) . CORRECTION INFORMATION IN THE OPERATOR OF THE DEVICE HAS BEEN SPECIFIED MORE FROM HEALTH PROFESSIONAL TO NURSE BASED ON THE CUSTOMER FEEDBACK. INFORMATION IN THE INITIAL REPORTER AND OCCUPATION HAS BEEN CORRECTED TO HEALTH PROFESSIONAL AND OTHER HEALTH PROFESSIONAL RESPECTIVELY BASED ON THE INITIAL REPORTER. INFORMATION IN INITIAL REPORTER CORRECTED FROM THE INITIAL REPORT 3005581270-2016-00006 TO THE BELOW: (B)(6). DESPITE OUR BEST EFFORTS CONTACT DETAILS FOR THE CONTACT PERSON FOR INITIAL REPORTER (HEALTHCARE FACILITY) COULD NOT BE OBTAINED FROM THE DISTRIBUTOR THAT ORIGINALLY REPORTED ADVERSE EVENT THAT HAPPENED IN THE HEALTHCARE FACILITY . DISTRIBUTOR ADVISED THEY CAN BE CONTACTED IN THE CASE OF ADDITIONAL INFORMATION REQUIRED. BELOW IS THE DISTRIBUTOR DETAILS: (B)(4).

    Additional Manufacturer Narrative · 1

    DHR FOR (B)(4) WAS OBTAINED AND REVIEWED. ALL MANUFACTURING WORK STEPS HAVE BEEN COMPLETED AND SIGNED FOR AS PER ROUTE CARD. IN PROCESS TEST FORM FOR GRASS ELECTRODES WAS REVIEWED. ALL TESTS WERE COMPLETED AND SIGNED OFF. NO FAILURES RECORDED. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A LETTER LISTING OUTSTANDING INFORMATION HAS BEEN SENT TO CUSTOMER TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO SUBMIT FOLLOW UP REPORT AND/OR EXPLAIN WHY REQUIRED INFORMATION WAS NOT PROVIDED AND STEPS TAKEN TO OBTAIN SUCH INFORMATION. DEVICE AVAILABLE FOR EVALUATION? - AWAITING CUSTOMER RESPONSE IF THE DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

    THE FIRST NIGHT OF USE, THREE PATIENTS HAVE HAD MAJOR SKIN RASHES AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777396 GRASS ELECTRODES GRASS GENUINE CUP ELECTRODES GXY NATUS MANUFACTURING LIMITED F-E5GH-30 10218683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other