BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    028066

    MDR report key: 14498222 · Received May 25, 2022

    Report

    Report Number
    9612330-2022-00031
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    March 28, 2022
    Report Date
    August 16, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). 3- BREAKOUT BOXES WITH CONNECTOR DAMAGE FROM ELECTRODE CONNECTOR DAMAGE: (1) SN: (B)(4) - BILLABLE, WARRANTY ENDED 3/14/2022 - SIEBEL DOESN'T SHOW ANY RECORD OF TROUBLESHOOTING BEING DONE TO CONFIRM FAILURE. BREAKOUT BOX WITH SN: (B)(4). EXCHANGE WAS DOCUMENTED UNDER SR 10150807. (2) SN: (B)(4) - WARRANTY ENDS 9/27/2022. (3) SN: (B)(4) - WARRANTY ENDS 9/27/2022. TH ELECTRODE CONNECTORS GET MELTED INSIDE BREAKOUT BOX CHANNEL INPUTS. ITS DESCRIBED AS PLASTIC GETS MELTED INSIDE. WHEN THEY PRY TO REMOVE THE ELECTRODE CONNECTOR, THIS CAUSES PHYSICAL DAMAGE TO CONNECTOR CHANNEL OPENING(S). THE METAL PIN INSIDE (COPPER) IS DARKER (BLACKEN) FROM THE HEAT FORMING THE BLACK COPPER OXIDE. THIS HAPPENS EVERY 2 MONTHS! THEY HAD REPLACED SOME OF THEIR OLDER HARDWARE. THE CUSTOMER SAID SAME ISSUE HAPPENED ON SOME OLDER HARDWARE TOO. PICTURES WERE SENT - IT IS HARD TO SEE THE INSIDE OF THE CONNECTOR CHANNEL TO GET TRUE VIEW OF DAMAGE. FROM PICTURES YOU CAN DISTINGUISH BAD CHANNEL OPENING TO NON-DAMAGE. LOT/SERIAL NUMBER:(B)(4). INSTALL DATE: (B)(6) 2021. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER HAZARD ID LINE 5.17 IN DOC-010378 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE CUSTOMER'S ALLEGEDLY DEFECTIVE BREAKOUT BOX WAS RECEIVED. CURRENTLY WAITING FOR CUSTOMER'S RESPONSE TO ADVERSE EVENT QUESTIONNAIRE AND INVESTIGATION RESULTS FROM ENGINEERING.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. DEVICE HISTORY WAS REVIEWED AND NO RELATED FAULTS/ISSUES FOUND. REPAIR DATA FROM THE PAST TWO YEARS FINDS NO REPAIRS ON THIS UNIT. THE AFFECTED PART WAS RETURNED AND THE FOLLOWING INVESTIGATION RESULTS WERE DOCUMENTED: INVESTIGATION RESULTS: BOTH UNITS INVESTIGATED (S/N (B)(6) HAD AN INPUT THAT HAD THE TIP OF AN ELECTRODE (OVERMOLD MATERIAL) DIN CONNECTOR BROKEN OFF IN THE HOLE. THE ELECTRODES USED WITH THE EMU40 USE TOUCH PROOF CONNECTORS AND THE OVERMOLD MATERIAL EXTENDS PAST THE END OF THE FEMALE CONTACT TO AVOID UNINTENDED ELECTRICAL CONTACT TO ANYTHING BESIDES A MATING CONNECTOR. THE UNITS WERE OPENED UP AND THE TIP OF THE ELECTRODE WAS ABLE TO BE REMOVED FROM THE PINS. THE LENGTH OF THE BROKEN ELECTRODE TIP IS APPROXIMATELY 4-5MM. ON UNIT 028066030445 THE TIP OF THE ELECTRODE WAS VERY FIRMLY ATTACHED TO THE PLASTIC MOLDING AROUND THE PINS AND HAD TO BE DISLODGED WITH A TOOL. THE DAMAGE TO THE PLASTIC HOUSING WAS FROM THE USER TRYING TO DIG THE ELECTRODE TIP OUT OF THE HOLE WITH A SMALL TOOL. THE PINS SHOWED NO CORROSION OR EVIDENCE OF DAMAGE FROM THERMAL OR CHEMICAL MEANS. THE GOLD PLATING OF THE PINS WAS SCRATCHED IN PLACES DUE TO THE TOOL THAT WAS USED TO ATTEMPT TO REMOVE THE PLASTIC TIP OF THE MATERIAL. THE ELECTRICAL SIGNALS THAT ARE CARRIED BY THE ELECTRODES ARE VERY SMALL AND DO NOT HAVE ENOUGH ENERGY TO CAUSE ANY OF THE COMPONENTS SUCH AS THE ELECTRODE CONNECTOR TO MELT. THERE WAS NO BLACK RESIDUE OR RESIDUE OF ANY KIND VISIBLE ON THE ELECTRODE PIN OR PLASTIC PART. THE CUSTOMER THOUGHT THEY WERE SEEING BLACK COPPER OXIDE BEING FORMED. WHEN THE UNIT WAS DISASSEMBLED THERE IS NO RESIDUE OF ANY TYPE OBSERVED, AND THE GOLD PLATING WOULD NEED TO BE REMOVED FROM THE BRASS PIN FOR ANY TYPE OF CORROSION TO OCCUR. THE DARKER APPEARANCE OF THE ELECTRODE WITH THE TIP BROKEN OFF IN IT IS DUE TO THE LACK OF A REFLECTION FROM THE BASE OF THE PIN AT THE BOTTOM OF THE HOLE. ROOT CAUSE/PROBABLE ROOT CAUSE: THE LIKELY CAUSE OF THIS ISSUE IS AN ELECTRODE CONNECTOR TIP BREAKING OFF IN THE AMPLIFIER DUE TO BEING CRACKED/DAMAGED NEAR THE TIP AND BEING HELD IN PLACE BY A SUBSTANCE SUCH AS CONDUCTIVE GEL OR A CLEANING AGENT THAT WAS PRESENT IN THE AMPLIFIER CONNECTOR HOLE. A CHEMICAL SUCH AS A CLEANING AGENT COULD CAUSE DAMAGE TO THE ELECTRODE TIPS IF IT WAS PRESENT IN THE BOTTOM OF THE HOLES, BUT NO INFORMATION ON THE CLEANING AGENTS USED WAS AVAILABLE. RECOMMENDED ACTIONS: MONITOR FOR RECURRENCE, ASK END USER POTENTIAL CLEANERS OR CHEMICALS THAT ARE USED ON THE AMPLIFIER OR ELECTRODE CONNECTORS THAT COULD CAUSE DAMAGE/DEGRADATION. CLOSURE RATIONALE: COMPLAINT VERIFIED, BEING TRACKED AS A TREND. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    EMU40EXQ BREAKOUT BOX - HEADBOX CONNECTOR OPENING(S) HAS DAMAGE DUE TO BROKEN ELECTRODES INSIDE BOX. THE ELECTRODE CONNECTORS GET MELTED INSIDE BREAKOUT BOX CHANNEL INPUTS. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    EMU40EXQ BREAKOUT BOX - HEADBOX CONNECTOR OPENING(S) HAS DAMAGE DUE TO BROKEN ELECTRODES INSIDE BOX. THE ELECTRODE CONNECTORS GET MELTED INSIDE BREAKOUT BOX CHANNEL INPUTS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342384 028066 028066 GWQ NATUS MEDICAL INCORPORATED 028066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown