BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ HD ERGOJUST VIDEO EXTENSION

    MDR report key: 10663044 · Received October 12, 2020

    Report

    Report Number
    9612330-2020-00010
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    October 3, 2020
    Report Date
    October 7, 2020
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2020. REFERENCE TO COMPLAINT (B)(4). TODATE, THE ALLEGEDLY DEFECTIVE PART HAS NOT BEEN RETURNED FOR EVALUATION. A 2ND REMINDER WAS SENT OUT TO THE CUSTOMER ON THE (B)(6) 2020, NO RESPONSE TODATE. RISK MANAGEMENT FILE REVIEW: PER HAZARD ID 6.4 OF DOC-010378 EEG/PSG RISK ASSESSMENT THE RISK IS MODERATE: 11.

    Additional Manufacturer Narrative · 0

    FOLLOW UP 003 (REFERENCE TO NATUS COMPLAINT #: (B)(4)). IP PTZ HD ERGOJUST VIDEO EXTENSION - THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN. THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME. THE ARM HITTING HER ARM RESULTED IN A BRUISE. IT HAS BEEN AT LEAST 45 DAYS SINCE THE CUSTOMER WAS INFORMED THAT THE RETURN OF THE PART IS NECESSARY FOR INVESTIGATION. THE PART HAS NOT BEEN RECEIVED BACK. EVALUATION IS UNABLE TO BE COMPLETED AS CUSTOMER HAS NOT RETURNED THE PRODUCT DESPITE MULTIPLE REQUESTS. REFERENCE TO DOC-010378, REV 40 - HAZARD ID: 6:11. PER RISK ASSESSMENT, THE INITIAL RISK = 9, RESIDUAL RISK:= 3, RBA-04 LOW. NO NEW RISKS INTRODUCED BY CONTROL MEASURE. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED. COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Additional Manufacturer Narrative · 0

    ON 05 FEB 2021 (REFERENCE TO NATUS COMPLAINT #: (B)(4)). TODATE, THE ALLEGEDLY DEFECTIVE PART HAS NOT BEEN RETURNED FOR EVALUATION. A 3RD REQUEST WILL BE SENT OUT TO THE CUSTOMER TO RETURN THE PART.

    Description of Event or Problem · 0

    IP PTZ HD ERGOJUST VIDEO EXTENSION: THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN.THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME THE ARM HITTING HER ARM RESULTED IN A BRUISE.

    Description of Event or Problem · 0

    IP PTZ HD ERGOJUST VIDEO EXTENSION - THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN.THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME THE ARM HITTING HER ARM RESULTED IN A BRUISE.

    Description of Event or Problem · 0

    IP PTZ HD ERGOJUST VIDEO EXTENSION - THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN.THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME. THE ARM HITTING HER ARM RESULTED IN A BRUISE.

    Additional Manufacturer Narrative · 1

    (B)(6) 2020 REFERENCE TO COMPLAINT # (B)(4). IP PTZ HD ERGOJUST VIDEO EXTENSION. THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN. THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME THE ARM HITTING HER ARM RESULTED IN A BRUISE. CURRENTLY WAITING FOR ALLEGEDLY DEFECTIVE PART TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IP PTZ HD ERGOJUST VIDEO EXTENSION. THE VIDEO ARM BROKE OFF AND HIT A TECHNICIAN. THE TECHNICIAN WAS IN TRANSIT TO A PATIENT ROOM AT THE TIME THE ARM HITTING HER ARM RESULTED IN A BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131615 IP PTZ HD ERGOJUST VIDEO EXTENSION IP PTZ HD ERGOJUST VIDEO EXTENSION GWQ NATUS MEDICAL INCORPORATED IP-HD-EC-VIDEO-EXT

    Patients

    Seq Age Sex Outcome Treatment
    1