BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS EMBLA NDX AMPLIFIER

    MDR report key: 10454390 · Received August 26, 2020

    Report

    Report Number
    9612330-2020-00008
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 13, 2020
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    PMA / PMN Number
    K180290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 18 NOV 2020 (FOLLOW UP 002) NATUS COMPLAINT #(B)(4). THE FOLLOWING STANDARD ELECTROENCEPHALOGRAPH RECORDING HARDWARE THAT WAS INCLUDED IN THE PK 1270 WAS RETURNED FOR INVESTIGATION: PRODUCT EXAMINATION AND FUNCTIONAL TESTING: PART 016862 NATUS BASE UNIT S/N (B)(6) - GENERAL CONDITION IS GOOD. THERE ARE SLIGHT SIGNS OF USAGE WITH A FEW MINOR SCRATCHES ON THE HOUSING AND PAINT ABRASION ON THE MOUNTING PLATE. PART 021919 NATUS EMBLA NDX BREAKOUT S/N (B)(6) - GENERAL CONDITION IS GOOD. A FEW PATCHES OF ADHESIVE RESIDUE ON THE FRONT AND BACK, PROBABLY FROM TAPE USED TO MANAGE ELECTRODE WIRES DURING STUDIES. THERE IS A PLASTIC COVER OVER THE HEADCAP CONNECTOR HELD IN PLACE WITH A PIECE OF SCOTCH TAPE. PART 013414 NATUS QUANTUM BREAKOUT TO BASE CABLE, 5M LOT J260444 - CABLE JACKET AND CONNECTOR HOUSINGS IN VERY GOOD CONDITION. TWO RIGHT ANGLE KINKS IN THE MIDDLE OF THE CABLE ABOUT SIX INCHES APART. THESE KINKS SHOULD NOT HAVE ANY IMPACT ON PERFORMANCE. PART 013414 NATUS QUANTUM BREAKOUT TO BASE CABLE, 5M LOT K330364 - CABLE JACKET AND CONNECTOR HOUSINGS IN VERY GOOD CONDITION. CABLE JACKET IS SLIGHTLY SOILED. THE SAME TWO KINKS, IN THE SAME PLACES ARE EVIDENT ON THIS CABLE AS WELL. AGAIN, THIS SHOULD NOT IMPACT PERFORMANCE THE INVESTIGATOR CONNECTED THE NDX BREAKOUT TO THE NATUS BASE UNIT USING THE 031414 LOT J260444 CABLE. CONNECTED THE BASE UNIT TO THE PC VIA USB CABLE. POWERED UP THE PC AND THE BASE UNIT. THE BASE UNIT RECOGNIZED AND CONNECTED TO THE NDX AS EXPECTED. LAUNCHED A STUDY ON THE COMPUTER WITHOUT ANY ISSUES. EXERCISED THE BASE FRONT PANEL SWITCHES AND ALL WORKED AS EXPECTED. THE INVESTIGATOR REMOVED THE CABLE AT THE NDX END AND WITNESSED NO EVIDENCE OF SPARKING. REPEATED CONNECTIONS AND DISCONNECTION SEVERAL TIMES WITH NO EVIDENCE OF SPARKING. REPEATED THE PROCESS AT THE BASE UNIT END OF THE CABLE, NO SPARKS. DIMMED THE LIGHTS AND REPEATEDLY DISCONNECTED/RECONNECTED BOTH ENDS OF THE CABLE, STILL NO EVIDENCE OF SPARKING. PERFORMED THE SAME SEQUENCE WITH CABLE 031414 LOT K330364, WITH THE SAME RESULTS. STILL NO EVIDENCE OF SPARKS WHEN DISCONNECTING OR CONNECTING THE COMMUNICATION CABLE AT THE BASE OR BREAKOUT END. THE INVESTIGATOR CANNOT REPLICATE THE REPORTED FAILURE MODE OF SPARKING WHEN DISCONNECTING THE BREAKOUT. THE BASE UNIT, BREAKOUT BOX AND BOTH CABLES OPERATE NORMALLY. THE INVESTIGATOR WAS UNABLE TO RECREATE THE REPORTED PROBLEM AND CAN THEREFORE NOT COME TO ANY CONCLUSION REGARDING THE ROOT CAUSE. THIS COMPLAINT COULD NOT BE VERIFIED AND WILL BE MONITORED FOR FUTURE OCCURRENCE. PER HAZARD ID 3.17 OF DOC-(B)(4)- EEG/PSG RISK ANALYSIS, THE RISK IS CONSIDERED MODERATE - 11. DHR REVIEW WAS NOT APPLICABLE BECAUSE PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY.

    Additional Manufacturer Narrative · 0

    UPDATE ON 24 SEPT 2020 (REF COMPLAINT NO. (B)(4)): PRODUCT EXAMINATION AND FUNCTIONAL TESTING: THE DEVICE WAS RETURNED. THE ENGINEERING TEAM LEAD IS CURRENTLY CONDUCTING THE INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A SPARK WAS OBSERVED BETWEEN THE BREAKOUT BOX AND CABLE.RETURNING ALL EQUIPMENT FOR INVESTIGATION. NO PATIENT INJURY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A SPARK WAS OBSERVED BETWEEN THE BREAKOUT BOX AND CABLE. RETURNING ALL EQUIPMENT FOR INVESTIGATION. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STANDARD ELECTROENCEPHALOGRAPH RECORDING HARDWARE WERE INCLUDED IN PK 1270: NATUS BASE UNIT PART 016862, SN: (B)(4). NATUS EMBLA NDX BREAKOUT PART 021919, SN: (B)(4). NATUS QUANTUM BREAKOUT TO BASE CABLE, 5M PART# 013414. THESE PARTS HAVE BEEN REQUESTED TO BE RETURNED FOR FULL INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SPARK WAS OBSERVED BETWEEN THE BREAKOUT BOX AND CABLE. RETURNING ALL EQUIPMENT FOR INVESTIGATION. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918944 NATUS EMBLA NDX AMPLIFIER NATUS EMBLA NDX AMPLIFIER GWQ NATUS MEDICAL INCORPORATED PK1270

    Patients

    Seq Age Sex Outcome Treatment
    1