BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ ERGOJUST VIDEO EXTENSION NO CAMERA

    MDR report key: 12818341 · Received November 16, 2021

    Report

    Report Number
    9612330-2021-00034
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    November 2, 2021
    Report Date
    January 10, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT (B)(4). 03 NOVEMBER 2021: TECHNICAL SERVICE HAVE SENT THE CUSTOMER A ADVERSE EVENT QUESTIONNAIRE TO COMPLETE. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 6.11 IN DOC-(B)(4) REV 49 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABLY OF OCCURRENCE HAS NOT CHANGED. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. CAPA TRENDING REVIEW WAS COMPLETED - RELATED TO CAPA(B)(4). FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REFERENCE TO NATUS COMPLAINT #(B)(4) RESPONSE FROM CUSTOMER STATES "AFFECTED PART WAS NOT IN USE ON PATIENT. FRAME WAS DAMAGED DURING TRANSPORT IN HOSPITAL. NO INJURIES. NO FURTHER FOLLOW UP ACTION HAS BEEN RECORDED OR CROSS REFERENCED IN THE SERVICE CALL FOR AT LEAST 30 DAYS. REVIEW OF CUSTOMER'S ACCOUNT FOUND NO ADDITIONAL RELATED CALLS. COMPLAINT WILL BE CLOSED BUT MAY REQUIRE FUTURE ACTION IF TRENDING SO PRESCRIBES. NO PRODUCT EXAMINATION WAS COMPUTED AS CUSTOMER DID NOT RETURN THE PRODUCT FOR EVALUATION. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. 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

    PART IP-VIDEO-EXT-NC. PART DESCRIPTION IP PTZ ERGOJUST VIDEO EXTENSION NO CAMERA. TOP ASSEMBLY IS NO LONGER HOLDING. THE ARM FELL OFF. IT WAS NOT IN USE ON PATIENT. FRAME WAS DAMAGED DURING TRANSPORT IN HOSPITAL. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART IP-VIDEO-EXT-NC. PART DESCRIPTION IP PTZ ERGOJUST VIDEO EXTENSION NO CAMERA. TOP ASSEMBLY IS NO LONGER HOLDING. THE ARM FELL OFF. IT WAS NOT IN USE ON PATIENT. FRAME WAS DAMAGED DURING TRANSPORT IN HOSPITAL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722907 IP PTZ ERGOJUST VIDEO EXTENSION NO CAMERA IP PTZ ERGOJUST VIDEO EXTENSION NO CAMERA GWQ NATUS MEDICAL INCORPORATED IP-VIDEO-EXT-NC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown