BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALUE LINE DCN, DISPOSABLE CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 20066268 · Received August 26, 2024

    Report

    Report Number
    3005581270-2024-00003
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT(B)(4) THE DP TEKNIKEL WAS REQUESTED TO CONTACT THE HOSPITAL AND REQUEST THE CUSTOMER TO RETURN THE REMAINING UNUSED NEEDLES AND THE NEEDLE CABLE / CABLE HOLDER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). UPDATE TO SECTION D4 EXPIRATION DATE. UPDATE TO SECTION H4 MANUFACTURER DATE. RISK REVIEW: PER (B)(4) REV 14 VALUE LINE DCN ELECTRODES RISK ANALYSIS SPREADSHEET - HAZARD ID 5.5 DATA LOSS. CAUSE - ERRONEOUS DATA TRANSFER / UNCLEAR READING DUE TO INCORRECT FUNCTION OF NEEDLE. EFFECT (HARM)- DATA WON'T BE RECORDED IF INCOMPATIBLE WITH AMPLIFIER. DELAY IN PROCEDURE / A NEW NEEDLE WOULD HAVE TO BE USED. RESIDUAL RISK - LOW. NO RELATED CAPAS. REVIEW OF DEVICE HISTORY RECORD SHOWED NO ANOMALIES. PRODUCT EXAMINATION: UPON REVIEW OF THE RETURNED NEEDLE PRODUCT, THE PRODUCT WAS COMPARED AGAINST (B)(4) VISUAL REFERENCE STANDARD FOR CONCENTRIC NEEDLES - NO FAILURES NOTED. NEEDLE CONTINUITY CHECKED AS PER PRODUCT DRAWING (B)(4) USING FLUKE MULTIMETER (CAL#1960) WITH ALL SAMPLES TESTED PASSING. UPON REVIEW OF THE RETURNED CABLE HOLDER PRODUCT, PART 15VCBL, LOT # 210927 SIGNS OF PRODUCT WEAR AND TEAR WERE NOTED. THE BLUE NEEDLE CONNECTOR SHOWED MATERIAL FRAYING FROM THE BLUE MOLDED MATERIAL WHICH MATES WITH THE NEEDLE WHICH COULD INDICATE SIGNIFICANT USE OF THE PRODUCT. ONE OF THE THREE SAMPLES RETURNED OF THE CABLE HOLDER 15VCBL (HOLDER) WAS MISSING PART OF THE LANTERN SPRING (GOLD COLORED PART 065Y002) CONNECTOR. INDENTATIONS WERE ALSO NOTED ON THE GOLD SPRING CONTACT TEST PROBE OF THE CABLE HOLDER. ASSEMBLED CABLE HOLDER AND NEEDLE SAMPLES ALL PASSED CONTINUITY TESTING. SIGNS OF WEAR AND TEAR NOTED ON THE CABLE HOLDERS DURING INVESTIGATION COULD POTENTIALLY GIVE RISE TO ISSUES DESCRIBED IN THE COMPLAINT. NO ISSUE TO NEEDLE PRODUCTS. ISSUE WAS FOUND WITH THE CABLE HOLDER. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/CABLE DAMAGE.

    Description of Event or Problem · 0

    PART 37V26 - DURING THE USE OF THE NEEDLES, ESPECIALLY IN THE INPUT ACTIVITY, IT WAS SEEN THAT IT WAS FREQUENTLY INTERRUPTED AND ALOT OF ARTIFACTS WERE OBSERVED. NO INJURIES.

    Description of Event or Problem · 0

    PART 37V26 - DURING THE USE OF THE NEEDLES, ESPECIALLY IN THE INPUT ACTIVITY, IT WAS SEEN THAT IT WAS FREQUENTLY INTERRUPTED AND ALOT OF ARTIFACTS WERE OBSERVED. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277531 VALUE LINE DCN, DISPOSABLE CONCENTRIC NEEDLE ELECTRODE VALUE LINE DCN, DISPOSABLE CONCENTRIC NEEDLE ELECTRODE IKT NATUS MANUFACTURING LIMITED 37V26 10C/24/V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown