BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    028066

    MDR report key: 14552277 · Received May 31, 2022

    Report

    Report Number
    9612330-2022-00033
    Event Type
    Malfunction
    Date Received
    May 31, 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) FOR 3RD SERIAL (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 (B)(4). (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: SEPTEMBER 28TH, 2021 AND SEPTEMBER 28TH, 2021. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER HAZARD ID LINE (B)(4) 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) FOR 3RD SERIAL (B)(6). 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. THE FOLLOWING INVESTIGATION RESULTS WERE DOCUMENTED: ENGINEERING INVESTIGATED THE ALLEGEDLY DAMAGED HEADBOX. INVESTIGATION DETERMINED "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." THE ISSUE WAS DETERMINED TO BE CAUSED BY "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." 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
    2678851 028066 028066 GWQ NATUS MEDICAL INCORPORATED 028066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown