BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED 7 CEILING TRIO

    MDR report key: 15594658 · Received October 13, 2022

    Report

    Report Number
    9681407-2022-00021
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 13, 2022
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    UDI-DI
    00887761995840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS CAUSED BY A THIRD PARTY COMPANY. THEREFORE, A FURTHER COMPLAINT INVESTIGATION AT TRUMPF MEDICAL WILL NOT IDENTIFY A ROOT CAUSE OR BRING NEW INFORMATION. TRUMPF MEDICAL IS REPORTING THIS EVENT TO HEALTH CANADA AS THE MEDICAL DEVICE "ILED 7 CEILING TRIO" IS INVOLVED. THE ROOT CAUSE FOR THE EVENT IS NOT RELATED TO TRUMPF MEDICAL/HILLROM. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DURING A CASE, A SCREW FELL OUT OF THE MONITOR HOLDER AND LANDED ON TO THE FLOOR AFTER 3RD PARTY INSTALLED THE MONITORS ON THE CUSTOMERS SYSTEM. NO HARM OR IMPACT TO A SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582010 ILED 7 CEILING TRIO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4068310 00887761995840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown