BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2862301 · Received November 29, 2012

    Report

    Report Number
    9710055-2012-00019
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE. HE FOUND THE RUBBER BUMPER TO BE IN CONFORMANCE WITH ITS SPECS AND IN GOOD CONDITION. HE WAS ABLE TO RE-POSITION THE BUMPER BACK INTO ITS ORIGINAL POSITION. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A F/U REPORT. EXEMPTION # (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES 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 BUMPER FELL OFF FROM THE SURGICAL LIGHT CEILING SUSPENSION DURING SURGERY. THE HOSPITAL DID NOT REPORT ANY INJURIES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS NONE FSY MAQUET SAS XTEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI