BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS PHOTIC STIM KIT

    MDR report key: 13541559 · Received February 16, 2022

    Report

    Report Number
    9612330-2022-00011
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 15, 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)(6). THE UNIT POWER SUPPLY APPARENTLY SHORTED OUT / EMITTED SPARKS DURING SETUP OF AN EEG. THE CUSTOMER REPORTED NO INJURY AND NO PATIENT INVOLVEMENT. WE WERE ADVISED THE UNIT IS OUT OF WARRANTY. THE POWER CORD / BRICK ON THIS UNIT HAS SOME SORT OF RESIDUE ON THEM AND WAS EXPLAINED TO BE RESIDUAL HYDROGEL THAT HAD DRIPPED THERE OVER TIME. PRELIMINARY ASSESSMENT IS THE POWER SUPPLY HAD BEEN HANGING BY THE CORD FOR A PERIOD OF TIME, AND TENSION ON THE CORD DURING MOVEMENT OF THE ROLLSTAND WAS CAUSING THE POWER SUPPLY BRICK TO TWIST OR SPIN AROUND, RESULTING IN FRAYING AND EVENTUAL SHORTING OUT OF THE CABLE AT THE POSITION WHERE IT MEETS THE BRICK. INSTALL DATE: 6/3/2015.. PER HAZARD ID 3.20 OF DOC-(B)(4) - EEG/PSG RISK ANALYSIS, THE RISK IS CONSIDERED LOW. A QUESTIONNAIRE WAS 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). CUSTOMER RESPONSE TO AE QUESTIONNAIRE: - NO DEATH OR SERIOUS INJURY REPORTED. - USER REALIZED THE CORD WAS FRAYED AFTER NOTICING THE SPARKS. - EVENT OCCURED (B)(6) 2022. - NO NON-NATUS DEVICES BEING USED AT THE TIME. - INITIAL REPORTER TO NATUS - ADMINISTRATOR. - NO ENVIRONMENTAL CONCERNS. 02-MAR-2022 TECHNICAL SERVICE ADMINISTRATOR ASKED CUSTOMER IF THEY WOULD RETURN PHOTIC STIM KIT, DESPITE NOT WANTING REPLACEMENT. OFFERED RETURN LABEL - AWAITING RESPONSE. THERE ARE NO RELATED CAPA'S. THERE IS NO SERVICE HISTORY FOR THIS PART.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). REFERENCE USER MANUAL 105706X, SECTION 3. WARNINGS AND CAUTIONS - INSPECT THE DEVICE PRIOR TO USE. DO NOT USE IF DAMAGED. CUSTOMER ADVISED THEY WOULD NOT BE RETURNING THE DEVICE. THEY ALSO SAID THEY DO NOT INTEND TO USE THE PHOTIC THAT WAS INVOLED IN THE SPARKING EVENT. THE DEVICE WILL NOT BE RETURNED FOR ENGINEERING EVALUATION. CLOSURE RATIONALE:COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. 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 - POWER CORD FRAYED / SPARKING / NOT WORKING. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART 003555 - NATUS PHOTIC STIM KIT - POWER CORD FRAYED / SPARKING / NOT WORKING. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART 003555 - NATUS PHOTIC STIM KIT - POWER CORD FRAYED / SPARKING / NOT WORKING. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620417 NATUS PHOTIC STIM KIT NATUS PHOTIC STIM KIT GWE NATUS MEDICAL INCORPORATED 003555 00382830015790

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown