BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2497937 · Received March 12, 2012

    Report

    Report Number
    9710055-2012-00004
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE. HE FOUND THAT THE LIGHT WAS SUSPENDED TO THE CEILING BY TWO OUT OF THE ORIGINAL FOUR MOUNTING BOLTS. IN NORMAL CONDITIONS, THE LIGHT MUST BE ATTACHED TO THE CEILING BY SIX BOLTS AND THREADED RODS. THE LONDON SERIES LIGHTS WERE SOLD BETWEEN 1980 AND 1990 AND OFFICIALLY DISCONTINUED IN 1991. MAQUET SAS OWNERSHIP OF THESE LIGHTS TOOK PLACE ON 2003 AND THE INSTALLATION RECORDS OF THESE LIGHTS WERE NOT PROVIDED AT THAT TIME. MAQUET HAS BEEN UNABLE TO DETERMINE IF THE FORMER MFR'S SALES AND SERVICE UNIT CONDUCTED THE INSTALLATION OF THE LIGHTS OR IF THEY WERE INSTALLED DIRECTLY BY A HOSPITAL CONTRACTOR. SHOULD ADD'L INFO BE DISCOVERED A F/U REPORT WILL BE SUBMITTED. THE LONDON SERIES YEARLY PREVENTIVE MAINTENANCE PROGRAM REQUESTS CUSTOMERS VERIFY THE SUSPENSION HARDWARE IS SECURE BY SHAKING THE SYSTEM. THE CUSTOMER INDICATED TO THE FST THAT THEY HAD NOT PERFORMED ROUTINE MAINTENANCE TO CHECK MOUNTING HARDWARE, NOR DO THEY HAVE AN ACTIVE SERVICE CONTRACT. THE LONDON LIGHTS WERE REMOVED FROM SERVICE AND MOVED TO A SEPARATE LOCATION. (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SURGICAL LIGHT FELL FROM CEILING DURING A PROCEDURE. LIGHT WAS "CAUGHT" BY CIRCULATOR AND WAS SUSPENDED BY TWO REMAINING MOUNTING BOLTS. THE PROCEDURE WAS COMPLETED IN THE OPERATING ROOM. THE HOSPITAL DID NOT REPORT INJURIES TO THE PT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1