BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET SAS

    MDR report key: 2427514 · Received January 16, 2012

    Report

    Report Number
    9710055-2012-00001
    Event Type
    Other
    Date Received
    January 16, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    MAQUET SAS
    Product Code
    FSS
    PMA / PMN Number
    K954169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICIAN AUTHORIZED BY MAQUET EVALUATED THE LIGHT, REPLACED THE BULB THAT EXPLODED AND THE BROKEN GLASS COVER. HE VERIFIED THAT THE SYSTEM WAS FUNCTIONAL AND THAT THE VOLTAGE AT THE BULB WAS WITHIN THE MANUFACTURER'S SPECIFICATIONS. MAQUET HAS NOT BEEN INFORMED OF ANY SERIOUS INJURIES TO THE ASSISTANT, NOR WAS ABLE TO DETERMINE THE PRIMARY CAUSE OF THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4). MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    DURING USE, THE HALOGEN BULB IN THE LIGHT HEAD EXPLODED AND BROKE THE GLASS COVER. THE HOSPITAL REPORTED THAT AN ASSISTANT HAD BEEN INJURED BY A PIECE OF GLASS IN A CHEEK BELOW THE EYE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS NONE FSS MAQUET SAS BLUE 30

    Patients

    Seq Age Sex Outcome Treatment
    1 Other