BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET, OPERATING-ROOM TABLE SYSTEM

    MDR report key: 3769901 · Received April 14, 2014

    Report

    Report Number
    8010652-2014-00008
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) INVESTIGATED THE DEVICES. THE ENTIRE SYSTEM HAS BEEN TESTED TOGETHER WITH THE BIOMED AND SURGICAL STAFF. THE EVENT COULD NOT BE REPRODUCED. THE ENTIRE SYSTEM WORKED AS SPECIFIED. DURING TRANSFER OF THE TABLE TOP, THE TABLE TOP IS AUTOMATICALLY LOCKED TO THE COLUMN WITH TWO LOCKING HOOKS UNTIL THE TABLE TOP HAS BEEN SAFELY TRANSFERRED TO THE TRANSPORTER. ONLY A COMBINATION OF TWO EVENTS OR FAULTS OCCURRING SIMULTANEOUSLY CAN LEAD TO THE DESCRIBED EVENT: BOTH SAFETY HOOKS ARE NOT LOCKED (LIKELY FROM AN OBSTACLE PREVENTING THE LATCHING MECHANISM FROM LOCKING INTO POSITION.) THE TRANSPORTER IS NOT IN THE CORRECT POSITION. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MAQUET OPERATING ROOM TABLE SYSTEM 1120 WAS USED DURING A SURGERY. AFTER THE PROCEDURE AND DURING THE TRANSFER OF THE TABLE TOP FROM THE COLUMN TO THE TRANSPORTER; THE TABLE TOP DETACHED FROM THE COLUMN WITHOUT BEING PROPERLY LOCKED ONTO THE TRANSPORTER. AS IT WAS NOT SECURED, THE TABLETOP TILTED AND THE PT SLID OFF OF THE TABLETOP ONTO THE FLOOR, SUFFERING AN ABRASION ON THE BACK. NO TREATMENT INFORMATION WAS PROVIDED(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228563 MAQUET, OPERATING-ROOM TABLE SYSTEM TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 1120.05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other