BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3142310 · Received May 21, 2013

    Report

    Report Number
    3008355164-2013-00126
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE BULB BURST IN THE LIGHT HEAD AND PARTICLES FELL THROUGH CRACKS IN THE COVER PLATE DURING AN UNSPECIFIED PROCEDURE. CUSTOMER REPORTED NO PT INJURY. (B)(4). REF NUMBER: 9710055-2013-00023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225126 MAQUET SAS FSY MAQUET SAS BLUE 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA