BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET, CONNECTION FIXTURE

    MDR report key: 2394092 · Received December 22, 2011

    Report

    Report Number
    8010652-2011-00009
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    November 14, 2011
    Report Date
    December 6, 2011
    Manufacturer
    MAQUET GMBH AND CO. KG
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONNECTION FIXTURE WAS CHECKED BY MAQUET FIELD REP TOGETHER WITH THE HOSPITAL'S MEDICAL ENGINEERING. NO ERROR COULD BE DETECTED WITH THE DEVICE. THE MFR BELIEVES THAT ONE OF THE THREE KNOB SCREWS WAS NOT FIXED PROPERLY AND CAME LOOSE, ALLOWING THE HEADREST TO ROCK BACKWARD. THE CUSTOMER WAS RE-TRAINED WITH RESPECT TO PROPER USAGE AND PRE-UTILIZATION INSPECTIONS AS INDICATED IN THE INSTRUCTIONS FOR USE. MAQUET INC 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. EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    DURING EXTUBATION, ONE OF THE THREE TENSIONING SCREWS CAME LOOSE, ALLOWING THE HEADREST TO ROCK BACKWARD. THE HEAD OF THE PT, WHICH WAS POSITIONED ON THE HEADREST, TILTED OVER DORSALLY. MRI OF CERVICAL SPINE SHOWED NO FINDING. THE PT SEEMS TO HAVE GOT A SLIGHT WHIPLASH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET, CONNECTION FIXTURE ACCESSORIES, OPERATING-ROOM, TABLE FWZ MAQUET GMBH AND CO. KG 1002.65A0

    Patients

    Seq Age Sex Outcome Treatment
    1