BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROLLEY CART

    MDR report key: 17562356 · Received August 17, 2023

    Report

    Report Number
    9612330-2023-00025
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 12, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    NYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS (B)(4). THE CUSTOMER SUBMITTED PHOTOS OF THE DAMAGED BRACKET AND REPLACEMENT PARTS WERE SENT TO THE CUSTOMER. PER DOC-010378 HAZARD ID 6.11, SEVERITY 11-CRITICAL; RISK LEVEL MODERATE. SERIAL NUMBER NOT APPLICABLE. INSTALL DATE: (B)(6) 2018. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE CUSTOMER REPORTED THEY NO LONGER HAVE THE PART AND CAN'T RECALL ITS WHEREABOUTS. NO FURTHER EVALUATION HAS BEEN CONDUCTED ON THE AFFECTED ITEM. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. A DEVICE HISTORY RECORD REVIEW WAS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. FAILLURE CONFIRMED: NO. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    TROLLEY CART - TRIPOD STAND BALL MOUNT BROKEN. THE CUSTOMER REPORTED THEIR VIDEOLOGY CAMERA'S MOUNTING BRACKET BROKE ON THEIR CART SYSTEM, WHEN THEY WERE MOVING IT. NO INJURIES.

    Description of Event or Problem · 0

    TROLLEY CART - TRIPOD STAND BALL MOUNT BROKEN. THE CUSTOMER REPORTED THEIR VIDEOLOGY CAMERA'S MOUNTING BRACKET BROKE ON THEIR CART SYSTEM, WHEN THEY WERE MOVING IT. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791915 TROLLEY CART TROLLEY CART NYE NATUS MEDICAL INCORPORATED 10295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other