BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1612894 · Received February 12, 2010

    Report

    Report Number
    9710055-2010-00003
    Event Type
    Other
    Date Received
    February 12, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 14, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN NORMAL CONDITIONS, THE COVER THAT FELL IS ASSEMBLED TO THE CEILING TUBE WITH TWO M6X16 NYLON SCREWS. ONE MAQUET SALES REP PRESENT IN THE HOSPITAL EVALUATED THE DEVICE. HE FOUND ONE SHEARED PLASTIC SCREW ON THE FLOOR BUT IT APPEARS THAT THE CLEANING CREW HAD ALREADY BEEN IN THE ROOM AND MUST HAVE SWEPT THE OTHER ONE AWAY. MAQUET SERVICE REPAIRED THE DEVICE AND VERIFIED THE OTHER UNITS IN THE HOSPITAL. NO OTHER DAMAGED SCREWS WERE FOUND. THE ROOT CAUSE FOR THE SHEARED SCREWS CAN NOT BE DETERMINED AT THIS TIME. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING 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 OR STAFF REPORTED THAT ONE METAL COVER, FROM THE CEILING TUBE OF THE SURGICAL LIGHT SYSTEM, FELL TO THE FLOOR. NO PTS WERE IN THE ROOM, NO INJURIES WERE REPORTED. (B) (4). (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1