BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    028066-R

    MDR report key: 12201325 · Received July 21, 2021

    Report

    Report Number
    9612330-2021-00015
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 29, 2021
    Report Date
    May 4, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). CORRECTION TO SECTION B1., H1., SECTION D4., UNIQUE IDENTIFIER (UDI) (B)(4), SERIAL NUMBER (B)(6). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 2.2 IN DOC-010378 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. TPI-1741 WAS CREATED TO ADDRESS THE ISSUE. THE AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). THE CUSTOMER PROVIDED PHOTOS OF THE SERIAL NUMBERS AND DAMAGE TO THE EMU40EX. THE SERVICE TECHNICIAN SENT THE QUESTIONNAIRE TO THE CUSTOMER. THE CUSTOMER RETURNED THE QUESTIONNAIRE AND REPORTED NO INJURIES. THEY STATED THE ISSUE HAS OCCURRED OVER TIME SINCE FEB-2021, AND THAT THE ATTACHED PLATE ON THE BREAKOUT BOX APPEARS MELTED. 3 REQUESTS WERE MADE FOR THE RETURN OF THE DEFECTIVE UNITS. THE SERVICE TECHNICIAN SPOKE WITH THE CUSTOMER ABOUT RETURNING THE DEFECTIVE UNITS. THE CUSTOMER REPORTED USING A LOOSE BACKPACK MOST OF THE TIME. THEY ALSO USED THE CASE PROVIDED BY NATUS AND REPORTED THEY OVERHEATED, AND THAT THE CLEAR PLASTIC POUCHES ON THE FRONT OF THE NATUS POUCHES TURNED BROWN AND HAD A MELTED LOOK. THE CUSTOMER STATED THAT THE UNITS BECAME HOT OR WARM TO THE TOUCH BEFORE THEY USED THEIR BACKPACKS AND PROVIDED PHOTOS. THE CLINICAL TEAM REPRESENTATIVE PROVIDED DOCUMENTATION REFERRING TO PREVIOUS CASE (B)(4) SUPPORTING THE USE OF NATUS POUCHES. THE SENIOR PRODUCT MANAGER INCLUDED THE GENERAL WARNING AND LIST FOR APPROVED ACCESSORIES. INCIDENT MAY BE CAUSED BY DEVICE MALFUNCTION, DETERIORATION IN CHARACTERISTICS AND/OR PERFORMANCE, CUSTOMER MISUSE OR INADEQUACY IN LABELING OR INSTRUCTIONS FOR USE. DHR REVIEW: SEP-14-2020. INSTALL DATE: SEP-28-2021. INVESTIGATION RESULT CODE: NEURO SBU/USER ERROR. CLOSURE RATIONALE: COMPLAINT VERIFIED, EXPECTED BEHAVIOR. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HEAT DAMAGE WITH THEIR EMU40 BREAKOUT BOX. THE ATTACHED PLATE ON THE BREAKOUT BOX APPEARS MELTED. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HEAT DAMAGE WITH THEIR EMU40 BREAKOUT BOX. THE ATTACHED PLATE ON THE BREAKOUT BOX APPEARS MELTED. NO INJURIES REPORTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE CUSTOMER REPORTED HEAT DAMAGE WITH EMU40EXQ BREAKOUT BOX. THE CUSTOMER RETURNED THE QUESTIONNAIRE AND REPORTED NO INJURIES. THEY STATED THE ISSUE HAS OCCURRED OVER TIME SINCE (B)(6) 2021, AND THAT THE ATTACHED PLATE ON THE BREAKOUT BOX APPEARS MELTED. THE CUSTOMER PROVIDED A PHOTO A DAMAGED BREAKOUT BOX. THE AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEAT DAMAGE WITH THEIR EMU40 BREAKOUT BOX. THE ATTACHED PLATE ON THE BREAKOUT BOX APPEARS MELTED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101998 028066-R 028066-R GWQ NATUS MEDICAL INCORPORATED 028066-R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown