BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2927766 · Received January 17, 2013

    Report

    Report Number
    9710055-2013-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPAIR WAS DONE BY THE HOSPITAL TECH TO KEEP THE OPERATING ROOM RUNNING. MAQUET HAS ORDERED A REPLACEMENT SEAL AND SCHEDULED A SERVICE VISIT TO EVALUATE THE DEVICE AND INSTALL A REPLACEMENT SEAL. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW-UP REPORT. EXEMPTION # (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS PROVIDE PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT A RUBBER SEAL FELL FROM THE CEILING TUBE OF THE SURGICAL LIGHT ONTO THE FLOOR. THE HOSPITAL DID NOT REPORT ANY INJURIES. FACTORY REF NUMBER: 2012-29892. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26564 MAQUET SAS FSY MAQUET SAS PWD55+DF K3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI