BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET SAS

    MDR report key: 2335575 · Received October 28, 2011

    Report

    Report Number
    9710055-2011-00008
    Event Type
    Other
    Date Received
    October 28, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH VISITED THE HOSPITAL AND EVALUATED THE DEVICE. THE FST REPLACED THE DAMAGED METAL STRIP AND VERIFIED SIMILAR SYSTEMS IN THE FACILITY. A SECOND DAMAGED METAL STRIP HAS ALSO BEEN REPLACED. THE ANALYSIS OF THE DEFECT SHOWS THAT THE METAL STRIP MAY COME OUT OF THE SIDE PLASTIC COVER WHEN THE MOUNTING IS NOT CORRECT OR IF THE PLASTIC COVER GUIDES ARE NOT CORRECTLY ASSEMBLED. INSTRUCTIONS TO MOUNT THE METAL STRIP ARE INCLUDED IN THE FLAT SCREEN SUPPORT INSTALLATION MANUAL. MOREOVER, ACCORDING TO THE POWERLED OPERATING MANUAL, ANNUAL MAINTENANCE SHOULD BE PERFORMED BY MAQUET CERTIFIED SERVICE PERSONNEL. IT IS PART OF THE ANNUAL MAINTENANCE PROGRAM, TO VERIFY FASTENING OF SIDE PLASTIC COVERS. MAQUET INC IS NOT THE PRIMARY SERVICE PROVIDER FOR THIS HOSPITAL. (B)(4). (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY (B)(4). PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT DURING A PROCEDURE, WHILE ATTEMPTING TO REPOSITION THE MONITOR HOLDER, A NURSE CUT HER FINGER ON A METAL COVER PROTRUDING FROM THE MONITOR ARM. NURSE REMAINED IN THE OPERATING ROOM FOR THE DURATION OF THE PROCEDURE AND WAS LATER TREATED WITH 4 STITCHES. PT AND PROCEDURE WERE UNAFFECTED BY THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FSY MAQUET SAS PWD77 DF XS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other