BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ HD ERGOJUST VIDEO EXTENSION

    MDR report key: 19763418 · Received July 17, 2024

    Report

    Report Number
    9612330-2024-00037
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 19, 2024
    Report Date
    October 11, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OMB
    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 REF NATUS COMPLAINT# (B)(4). PICTURES OF THE BROKEN VIDEO EXTENSION WERE PROVIDED. INVESTIGATION RESULTS: S/N: (B)(6) IS A POST CAPA003910 UNIT. ITS CONFIRMED IT'S AN UPDATED MAST. ROOT CAUSE/PROBABLE ROOT CAUSE: WELD FAILURE - ISSUE RELATED TO CAPA003757. RECOMMENDED ACTIONS: CAPA003910 ADDRESSES THE ISSUE. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/PHYSICAL DAMAGE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT (B)(4). PICTURES OF THE BROKEN VIDEO EXTENSION WERE PROVIDED. THE PART WAS REPLACED AND THE CUSTOMER WAS REQUESTED TO RETURN THE AFFECTED PART. RISK REVIEW: PER (B)(6) REV 71 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET. HAZARD 6.11 DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECTS (HARM): RANGE FROM CLINICALLY INSIGNIFICANT TO IRREVERSIBLE INJURY RESULTING FROM DIRECT PHYSICAL INJURY. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN (B)(4), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    IP PTZ HD ERGOJUST VIDEO EXTENSION - CUSTOMER REPORTED A BROKEN VIDEO EXTENSION AND THE ENTIRE CART WAS CRACKED AND TILTING. NO INJURIES.

    Description of Event or Problem · 0

    IP PTZ HD ERGOJUST VIDEO EXTENSION - CUSTOMER REPORTED A BROKEN VIDEO EXTENSION AND THE ENTIRE CART WAS CRACKED AND TILTING. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363788 IP PTZ HD ERGOJUST VIDEO EXTENSION IP PTZ HD ERGOJUST VIDEO EXTENSION OMB NATUS MEDICAL INCORPORATED IP-HD-EC-VIDEO-EXT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown