BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 4706461 · Received April 16, 2015

    Report

    Report Number
    9710055-2015-00036
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    February 26, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL TECHNICIAN REVIEWED THE DEVICE AND COULD NOT FIND ANY DAMAGES TO THE RUBBER BUMPER. HE REPLACED THE BUMPER AND RETURNED THE UNIT BACK TO USE. A MAQUET FIELD SERVICE TECHNICIAN (FST) INVESTIGATED EVERY ENDCAP IN ALL THE AVAILABLE ROOMS INCLUDING RM5 AND DIDN'T WITNESS ANY OTHER MISSING, DAMAGED, OR MISPLACED CAPS. ACCORDING TO TESTS PERFORMED DURING DESIGN VERIFICATION ACTIVITIES, THIS TYPE OF FAILURE CAN BE CAUSED BY REPEATED COLLISIONS/IMPACTS TO THE CUPOLA. THE POWERLED SERIES OPERATING MANUAL INCLUDES A VERIFICATION OF THE COVER DURING YEARLY MAINTENANCE. THE CUSTOMER REPORTED THIS EVENT TO FDA UNDER THE MDR # 0504540000-2015-8002.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT A CAP FELL ONTO THE INSTRUMENT TABLE DURING A SURGERY. THE SURGERY WAS DELAYED WHILE THE DRAPE AND INSTRUMENTS WERE REPLACED. THERE WAS NO DIRECT IMPACT ON THE PT OTHER THAN ADDITIONAL TIME UNDER ANESTHESIA DURING THE DELAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255706 POWERLED FSY MAQUET S.A.S PWD77+SFHDRK3

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER THERAPIES IN USE ON PT: NA| OTHER DEVICES IN USE ON PT: NA