BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMALIX

    MDR report key: 4092361 · Received September 4, 2014

    Report

    Report Number
    9710055-2014-00070
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K982063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FST HAS BEEN ABLE TO VERIFY THAT THIS CUPOLA CONFORMED TO SPECIFICATIONS IN TERMS OF LIGHT ILLUMINATION. THE MEASURED VALUES WERE IN ACCORDANCE WITH THE DEVICE'S LABELING AND WITH THE INTERNATIONAL STANDARD. THE MANUFACTURER'S OPERATIONS MANUAL SUGGESTS THAT THE SURGICAL TEAM MUST VERIFY THAT THE WOUND IS IRRIGATED DURING THE OPERATION AND ADAPT THE ILLUMINATION LEVEL TO AVOID DEHYDRATION OF THE TISSUE. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL ENGINEER INFORMED A FIELD SERVICE TECHNICIAN (FST) THAT BURN DAMAGE ON THE THORAX REGION NEAR THE STERNOTOMY WAS CAUSED BY THE CUPOLA PRIMALIX 8000. THE SURGERY DURATION WAS 14:00 TO 19:00. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541556 PRISMALIX FSY MAQUET SAS PRX8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other