BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2982206 · Received February 15, 2013

    Report

    Report Number
    9710055-2013-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SVC TECH (FST) VISITED THE FACILITY AND EVALUATED THE DEVICE. HE DISCOVERED THE RETAINING SCREW WHICH SECURES THE PROTECTIVE RING MISSING. MAQUET WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE MISSING SCREW. HOWEVER, AS A PRECAUTION, THE MAQUET FST REPAIRED THE LIGHT, AND INSPECTED THE OTHER 12 MAQUET LIGHTS IN THE FACILITY; NO FURTHER INSTANCES OF INCORRECTLY MOUNTED RINGS WERE FOUND. EXEMPTION NUMBER (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

    WITH THE PT IN THE ROOM, BUT PRIOR TO ANY SURGERY, THE OPERATING ROOM STAFF FOUND THE PROTECTIVE RING OF THE SURGICAL CUPOLA WAS IN ITS UPPER POSITION. THIS LEFT THE CUPOLA UNSECURED. THE USERS RE-POSITIONED THE SLEEVE, AND COMPLETED THE PROCEDURE. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69414 MAQUET SAS FSY MAQUET SAS POWERLED

    Patients

    Seq Age Sex Outcome Treatment
    1 NI