BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMP MODULE REPLACEMENT MLX

    MDR report key: 11045733 · Received December 21, 2020

    Report

    Report Number
    2523190-2020-00155
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 24, 2020
    Report Date
    March 3, 2021
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LAMP MODULE (001320LX) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT DURING USE OF THE LAMP REPLACEMENT MLZ, THE LAMP DID NOT ILLUMINATE WHEN THE POWER WAS TURNED ON DURING A CORONARY ARTERY BYPASS GRAFT CABG) SURGERY ON (B)(6) 2020. TOTAL LAMP USAGE WAS AT 300 HOURS. ANOTHER LAMP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MINUTE SURGICAL DELAY BUT NO ADVERSE CONSEQUENCE TO THE PATIENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516920 LAMP MODULE REPLACEMENT MLX N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1