BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 3831983 · Received March 7, 2014

    Report

    Report Number
    9710055-2014-00013
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REMOUNTED THE COVER AT THE END OF THE PROCEDURE, AND SEALED IT TO THE CEILING SUSPENSION USING A SILICON ADHESIVE. A MAQUET FIELD SERVICE TECHNICIAN INSPECTED THE DEVICE, SECURED THE COVER TO THE SUSPENSION WITH SCREWS, AND RETURNED THE DEVICE TO SERVICE. ACCORDING TO TESTS PERFORMED DURING DESIGN VERIFICATION ACTIVITIES, THIS TYPE OF FAILURE CAN BE CAUSED BY REPEATED COLLISIONS/IMPACTS TO THE CUPOLA. THE POWERED SERIES OPERATING MANUAL INCLUDES A VERIFICATION OF THE BUMPERS DURING YEARLY MAINTENANCES. EXEMPTION #(B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED I THIS REPORT.

    Description of Event or Problem · 1

    MAQUET FIELD SERVICE TECHNICIAN WAS INFORMED BY THE FACILITY BIOMED THAT THE GRAY RUBBER COVER ON THE BOTTOM OF THE CEILING SUSPENSION FELL OFF DURING A PROCEDURE. NO INJURIES WERE REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139050 POWERLED FSY MAQUET S.A. PWD73+SFHDRK3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA