BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2910261 · Received November 20, 2012

    Report

    Report Number
    9710055-2012-00017
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MAQUET S.A.S.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SENT A NEW RUBBER SEAL TO THE HOSP BIOMEDICAL ENGINEERING DEPARTMENT AS THEY WILL BE CONDUCTING THE CUPOLA REPAIR. MAQUET HAS INSTRUCTED THE HOSP TO RETURN THE REMOVED SEAL FOR EVAL AFTER THE REPAIR IS COMPLETE. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A F/U REPORT. THE LAST PREVENTIVE MAINTENANCE ON THIS DEVICE WAS DONE IN (B)(4) 2012 BY A MAQUET TECHNICIAN. NO ISSUE WERE REPORTED AT THIS TIME. EXEMPTION #(B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT THE RUBBER SEAL ON THE PERIPHERY OF THE CUPOLA CRUMBLED AND THAT SMALL PIECES FELL ON THE OPERATING TABLE DURING SURGERY (NOT IN THE WOUND AREA). NO INJURIES WERE REPORTED, THE OPERATION OF THE LIGHT WAS NOT AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS NONE FSY MAQUET S.A.S. POWERLED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI