BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2862299 · Received November 29, 2012

    Report

    Report Number
    9710055-2012-00020
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MAQUET SAS.
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) INSPECTED THE DEVICE AND FOUND THAT THE SLEEVE SECURING THE LIGHT HEAD TO THE SPRING ARM WAS CRACKED, ALLOWING THE RETAINING PIN WHICH SECURES THE LIGHT HEAD TO THE SPRING ARM TO MOVE OUT OF POSITION, FACILITATING THE LIGHT HEAD DETACHMENT. THE FST HAS REPLACED THE DAMAGED SLEEVE AND RETURNED THE LIGHT TO SERVICE. ADDITIONALLY, THE FST INSPECTED THE SLEEVES IN THE OTHER ROOMS TO ENSURE NO ADD'L SLEEVES WERE DAMAGED. EXEMPTION: (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET SAS 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 SURGICAL CUPOLA FELL DOWN WHILE A NURSE WAS PRE-POSITIONING IT PRIOR TO A SURGERY, WITHOUT PT IN THE OPERATING ROOM. THE CUSTOMER DID NOT REPORT ANY INJURIES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS NONE FTD MAQUET SAS. HANAULUX 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI