BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2009-00001

    MDR report key: 1343366 · Received February 27, 2009

    Report

    Report Number
    9710055-2009-00001
    Event Type
    Other
    Date Received
    February 27, 2009
    Product Code
    FTD
    PMA / PMN Number
    k895715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINING RING MAINTAINS IN THE CORRECT POSITIONING OF THE SAFETY PIN. WITH THE SAFETY PIN IN ITS PROPER POSITION, THERE IS NO CHANCE OF DAMAGE TO THE RETAINING RING. IT IS SUSPECTED THAT THE SAFETY PIN WAS OUT OF POSITION, LEADING TO ABNORMAL STRESS UPON THE RETAINING RING WHICH LED TO ITS FAILURE. THE MAQUET FOREIGN COUNTRY MAINTENANCE PROGRAM REQUIRES TO MAKE A VISUAL CHECK OF THE RETAINING RING EVERY YEAR. THE HOSP DID NOT HAVE A MAINTENANCE CONTRACT WITH MAQUET FOREIGN COUNTRY FOR THE INVOLVED MEDICAL DEVICE. THE BROKEN SPRING ARM IS NOW SCRAPPED AND REPLACED SO THE INVOLVED MEDICAL DEVICE IS NOW REPAIRED. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET FOREIGN COUNTRY PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FTD

    Patients

    Seq Age Sex Outcome Treatment
    1