BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1622884 · Received February 25, 2010

    Report

    Report Number
    9710055-2010-00004
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SERVICE TECH VISITED THE CUSTOMER AND EVALUATED THE DEVICE. EVIDENCE OF SMOKE WAS FOUND ON PAINT AT CUPOLA UPPER FORK WHERE IT CONNECTS TO VERTICAL SPRING ARM. NO VISIBLE DAMAGE WAS OBSERVED ON CABLING, GREASE OR BOARDS. NO EVIDENCE OF DAMAGE TO PLASTIC WAS OBSERVED ON 5 POLE CONTACTOR. MAQUET SERVICE TRACED THE FAILURE TO A BLOWN FUSE IN THE LIGHT POWER SUPPLY. IT IS BELIEVED THAT THE SMOKE FROM THIS EVENT TRAVELED THROUGH THE LIGHT AND EXITED AT THE UPPER FORK. AFTER REPAIRING THE FUSE AND REPLACING THE CUPOLA, THE LIGHT WAS FULLY OPERATIONAL. UPON DISCUSSIONS WITH THE HOSPITAL STAFF, IT WAS LEARNED THAT THE HOSPITAL STAFF HAD WORKED ON THE LIGHT THE PREVIOUS DAY WITHOUT POWERING THE UNIT DOWN, CAUSING THIS SHORT. THE POWERLED OPERATING MANUAL (B) (4) INCLUDES THE FOLLOWING WARNING IN THE MAINTENANCE SECTION: DISMANTLING CERTAIN ELEMENTS MAY AFFECT OPERATION AND SAFETY. FOR EXAMPLE, WHEN SERVICING THE ELECTRICAL POWER SUPPLY OR THE SUSPENSION ARM AND BALANCE SYSTEM. CONTACT THE AUTHORIZED MAQUET AFTER-SALES SERVICE DEPT FOR THIS TYPE OF INSPECTION. 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

    MAQUET INC SERVICE WAS INFORMED THAT THE LIGHT WAS NON-FUNCTIONAL. THE CUSTOMER REPORTED THAT SMOKE CAME OUT OF LIGHT CUPOLA DURING SURGICAL PROCEDURE AND FILLED THE ROOM. (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