BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ ERGOJUST VIDEO EXTENSION

    MDR report key: 12647099 · Received October 18, 2021

    Report

    Report Number
    9612330-2021-00031
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    October 3, 2021
    Report Date
    December 13, 2021
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REFERENCE TO NATUS COMPLAINT# (B)(4). SECTION D4: UDI DOCUMENTED AS (B)(4). THE AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 (REFERENCE TO NATUS COMPLAINT# (B)(4)). ROOT CAUSE FOR FAILURE IS THE BRACKET THAT WAS PROVIDED TO THE CUSTOMER AS PART OF A FIELD CORRECTION ACTION REFERENCE TO CAPA003910 WAS NOT INSTALLED. THE CUSTOMER HAD SIGNED OFF ON THE FCA BRACKET INSTALLATION FOR THIS SERIAL NUMBER BUT PICTURES THAT WERE PROVIDED, CLEARLY SHOW NO BRACKET ATTACHED TO THE FAILED VIDEO EXTENSION. CUSTOMER ALSO CONFIRMED THERE WAS NO FCA BRACKET INSTALLED AT THE TIME OF THE FAILURE. CAPA003910 WAS CLOSED (B)(6) 2019. INVESTIGATION RESULT CODE: NEURO SBU/USER ERROR CLOSURE RATIONALE: NO ACTION NECESSARY, KNOWN ISSUE OR PREVIOUSLY INVESTIGATED. OTHER CLOSURE RATIONALE: 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

    IT WAS REPORTED BY THE CUSTOMER THAT THE POLE FROM THE IP PTZ ERGOJUST VIDEO EXTENSION CART THAT HOLDS THE CAMERA, SNAPPED NEAR THE WELDING SITE AND FELL ON THE EEG TECHNICIANS HEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE POLE FROM THE IP PTZ ERGOJUST VIDEO EXTENSION CART THAT HOLDS THE CAMERA, SNAPPED NEAR THE WELDING SITE AND FELL ON THE EEG TECHNICIANS HEAD.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REFERENCE TO NATUS COMPLAINT# (B)(4). NO UDI NO. RECORDED AS VIDEO EXTENSION IS NOT A MEDICAL DEVICE. SERIAL NUMBER OF THE DELL PC FOR THIS CART WAS DOCUMENTED AS (B)(4). PER HAZARD ID 6.4 OF (B)(4) - EEG/PSG RISK ANALYSIS, THE RISK IS CONSIDERED LOW. CAPA REVIEW: CAPA (B)(4) (CLOSED), CAPA (B)(4) (CLOSED). NO INJURY WAS REPORTED. THE AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE POLE FROM THE IP PTZ ERGOJUST VIDEO EXTENSION CART THAT HOLDS THE CAMERA, SNAPPED NEAR THE WELDING SITE AND FELL ON THE EEG TECHNICIANS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545501 IP PTZ ERGOJUST VIDEO EXTENSION IP PTZ ERGOJUST VIDEO EXTENSION GWQ NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female