BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX 3000

    MDR report key: 4657928 · Received April 1, 2015

    Report

    Report Number
    9710055-2015-00033
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    MAQUET SAS
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE HLX SERIES LIGHT SYSTEM IS NOT MARKETED IN THE US. THIS REPORT HAS BEEN MADE DUE TO A SIMILARITY WITH DEVICES MARKETED BY MAQUET IN THE US. A MAQUET SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT MOST PARTS OF THE SYSTEM (SUSPENSION, LIGHTHEAD) WERE RUSTED. THE CUSTOMER INFORMED THE TECHNICIAN THAT FUMIGATION IS USED TO DISINFECT THE PRODUCT. THE HLX SERIES OPERATING MANUAL INCLUDES SOME GENERAL INSTRUCTIONS CONCERNING CLEANING. IN PARTICULAR, IT IS MENTIONED THAT "FUMIGATION METHODS ARE UNSUITABLE FOR DISINFECTING THE UNIT AND MUST NOT BE USED. A PROPOSAL HAS BEEN SUBMITTED TO THE HOSP TO REPLACE THE AFFECTED PARTS.

    Description of Event or Problem · 1

    CUSTOMER INFORMED MAQUET THAT THE SURGICAL LIGHT WAS RUSTED AND PAINT WAS MISSING ON SOME PARTS OF THE LIGHT. NO INJURIES WERE REPORTED. FACTORY REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214562 HLX 3000 LIGHT, SURGICAL BYX MAQUET SAS H5H3H3

    Patients

    Seq Age Sex Outcome Treatment
    1