BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2956857 · Received February 1, 2013

    Report

    Report Number
    9710055-2013-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED AS THE 3000 SERIES LIGHT SHARES A COMMON DESIGN WITH DEVICES MARKETED BY MAQUET IN THE UNITED STATES. THE HANAULUX 3000 SERIES IS NOT SOLD IN THE UNITED STATES. A MAQUET MAINTENANCE TECH VISITED THE HOSP AND FOUND THAT THE FRONT PIVOT OF THE SPRING ARM WAS BROKEN. HE REPLACED THE SPRING ARM WITH A NEW ONE AND RETURNED THE UNIT TO SERVICE. THE MAQUET TECH OFFERED TO INSPECT ALL SIMILAR UNITS AT THIS FACILITY AND RECOMMENDED A PREVENTATIVE MAINTENANCE CONTRACT WITH MAQUET. THE CUSTOMER HAS NOT RESPONDED TO THE OFFER. MAQUET IS NOT THE PRIMARY SERVICE PROVIDER FOR THIS DEVICE. MAQUET SERVICE LAST INSPECTED THESE LIGHTS IN 2010 AND FOUND NO ISSUES. DURING THE 2010 VISIT, THE CUSTOMER WAS INSTRUCTED THAT THE HANAULUX 3000 SERIES REQUIRES AN ANNUAL INSPECTION OF THE SPRING ARM AS PART OF ITS PREVENTIVE MAINTENANCE PROGRAM. (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    AFTER SURGERY, A NURSE WAS MOVING THE LIGHT WHEN THE CUPOLA DETACHED FROM THE SPRING ARM. THE LIGHT HEAD WAS RETAINED BY THE CABLES. THERE WAS NO PT IN THE ROOM, AND NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43749 MAQUET SAS NA FTD MAQUET SAS HANAULUX 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI