BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1630407 · Received March 5, 2010

    Report

    Report Number
    9710055-2010-00005
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    December 23, 2009
    Report Date
    February 3, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SERVICE TECHNICIAN VISITED THE CUSTOMER AND EVALUATED THE DEVICE. HE FOUND THAT THE LIGHT RETAINING CLIP WAS WORN AND BENT OPEN ALLOWING THE LIGHT TO LOOSEN FROM THE ARMS. SOME WASHERS WERE ALSO MISSING. HE REPLACED THE LOCKING CLIP ASSEMBLY AND VERIFIED THE LIGHT WAS FUNCTIONING PROPERLY. THE LIGHT HAS BEEN RETURNED TO SERVICE. THE HANAULUX LONDON LIGHT HAD BEEN DISMOUNTED A FEW WEEKS BEFORE THE INCIDENT FOR A DEMO AND RE-INSTALLED AFTER THE TRIAL WAS OVER. THE ORIGINAL WORN CLIP SHOULD HAVE BEEN REPLACED, BUT WAS RE-USED. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LOWER LIGHT ARM WAS SEPARATING FROM THE UPPER LIGHT ARM ASSEMBLY. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET FSY MAQUET S.A. CITY SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1