BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS PHOTIC STIM KIT

    MDR report key: 14019522 · Received April 6, 2022

    Report

    Report Number
    9612330-2022-00019
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    February 16, 2022
    Report Date
    June 14, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWE
    UDI-DI
    00382830015790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE EEG TECHNICIAN REPORTED THAT DURING THE SETUP OF ONE EEG, HE HEARD AND SAW SPARKING ON PART OF THE PHOTIC STIMULATOR'S POWER CORD, SPECIFICALLY A PART OF THE CORD NEAR ITS "BOXY" SECTION (SIMILAR TO HOW SOME COMPUTER/LAPTOP POWER CORDS HAVE A "BOXY" SECTION IN THE MIDDLE). WHEN HE WITNESSED THIS SPARKING/ELECTRICAL DISCHARGE, HE ALSO REALIZED THAT THE ELECTRICAL POWER CORD WAS FRAYED AND THAT THE INTERNAL METAL WIRES WERE EXPOSED AT THAT ELECTRICAL DISCHARGE'S LOCATION. HE THEN SUBSEQUENTLY FOUND THAT THE PHOTIC STIMULATOR WOULD NOT FLASH LIGHT ANYMORE, WHETHER IT WAS CONTROLLED FROM THE EEG DESKTOP COMPUTER OR BY THE MANUAL TEST BUTTON ON THE PHOTIC STIMULATOR ITSELF. HE ASSUMES THIS IS THE PRIMARY REASON WHY THE PHOTIC STIMULATOR SEEMS OR IS UNUSABLE NOW. HE HAS PICTURES OF THE STIMULATOR ITSELF AND THE DAMAGE TO IT, THE FRAYED POWER CORD. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 4.5 IN (B)(4) XLTEK EEG PSG RISK ANALYSIS SPREADSHEET. INSTALL DATE: (B)(6) 2015. REQUESTS HAVE BEEN SENT OUT FOR THE RETURN OF THE AFFECTED PRODUCT - NO PRODUCT HAS BEEN RETURNED TO DATE. A QUESTIONNAIRE WAS ALSO SENT TO THE CUSTOMER FOR ADDITIONAL INFORMATION AND FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THREE REQUESTS WERE MADE FOR THE RETURN OF THE AFFECTED PRODUCT. THE PRODUCT WAS NOT RETURNED. THE CUSTOMER PROVIDED PHOTOS OF THE AFFECTED PRODUCT AND ENGINEERING REVIEWED AND PROVIDED THE FOLLOWING ANALYSIS: "AC ADAPTER SEEMS TO BE COVERED WITH LIQUID RESIDUE (ACETONE?), POWER CORD IS STRIPPED AND WIRE EXPOSED. CONDITION DUE TO WEAR AND TEAR, AC ADAPTER SHOULD BE REPLACED. NO OTHER CUSTOMERS HAVE REPORTED SIMILAR COMPLAINTS." THIS FAILURE WAS CONFIRMED. RESULT CODE:NEURO SBU/CONTAMINATION. COMPLAINT VERIFIED, ISOLATED INCIDENT AND MONITOR FOR FUTURE OCCURRENCE. BASED ON EVALUATION OF THIS COMPLAINT THERE IS NO 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

    PART 003555 - NATUS PHOTIC STIM KIT PHOTIC POWER CABLE IS BROKEN. CUSTOMER REPORTED THEY "HEARD AND SAW SPARKING ON PART OF THE PHOTIC STIMULATOR'S POWER CORD." THE CUSTOMER STATED WHEN THEY WITNESSED THE SPARKING/ELECTRICAL DISCHARGE, THE ELECTRICAL POWER CORD WAS FRAY AND THE INTERNAL METAL WIRES WERE EXPOSED AT THE ELECTRICAL DISCHARGE'S LOCATION. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART 003555 - NATUS PHOTIC STIM KIT. PHOTIC POWER CABLE IS BROKEN. CUSTOMER REPORTED THEY "HEARD AND SAW SPARKING ON PART OF THE PHOTIC STIMULATOR'S POWER CORD." THE CUSTOMER STATED WHEN THEY WITNESSED THE SPARKING/ELECTRICAL DISCHARGE, THE ELECTRICAL POWER CORD WAS FRAY AND THE INTERNAL METAL WIRES WERE EXPOSED AT THE ELECTRICAL DISCHARGE'S LOCATION. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899656 NATUS PHOTIC STIM KIT NATUS PHOTIC STIM KIT GWE NATUS MEDICAL INCORPORATED 003555 00382830015790

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown