BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3192579 · Received June 21, 2013

    Report

    Report Number
    9710055-2013-00025
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K895715
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET IS NOT THE PRIMARY SERVICE PROVIDER FOR THIS DEVICE; THE HOSPITAL HAS CONTRACTED WITH A THIRD PARTY FOR MAINTENANCE. MAQUET'S SALES AND SERVICE UNIT HAS PROVIDED THEIR BIOMED WITH THE PART NUMBERS REQUIRED TO FACILITATE THE REPAIR. THE HANAULUX 2000 SERIES OPERATING MANUAL MENTIONS THAT THE PRODUCTS ARE TO BE INSPECTED BY THE OPERATOR EVERY SIX MONTHS WITH ATTENTION TO DEFECTS IN PAINT WORK. (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 IN THIS REPORT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283670 MAQUET SAS FTD MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1