BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET, O.R. TABLE SYSTEM 1120

    MDR report key: 2480523 · Received February 29, 2012

    Report

    Report Number
    8010652-2012-00005
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 3, 2012
    Manufacturer
    MAQUET GMBH AND CO., KG.
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN WAS SENT TO EXAMINE THE TABLE. (NOTE MAQUET IS NOT THE PRIMARY SERVICE PROVIDER, THE HOSPITAL MAINTAINS THIS TABLE). THE FST FOUND TWO SERIOUS DEFICIENCIES CONSISTENT WITH A LACK OF PROPER SERVICE MAINTENANCE: THE SAFETY SWITCH IN THE COLUMN USED TO DETECT THE TRANSPORTER WAS FOUND OUT OF POSITION, RENDERING IT INEFFECTIVE. THE SENSORS USED TO VERIFY HORIZONTAL ALIGNMENT WERE POSITIONED WRONG SO THAT THE HORIZONTAL ALIGNMENT OF THE COLUMN HEAD WAS APPROX 5 - 7 DEGREES OUT OF THE CORRECT POSITION. GIVEN THIS DATA, IT'S PRESUMED THAT EITHER THE TRANSPORTER WASN'T DRIVEN TO THE PROPER TRANSFER POSITION OR MORE LIKELY, THE COLUMN HEAD WASN'T ALIGNED CORRECTLY BECAUSE OF THE INCORRECT ZERO POSITION. IN EITHER SCENARIO, MAQUET BELIEVED THAT DURING THE INITIAL LIFTING OF THE COLUMN, THE PINS OF THE TABLE TOP COULDN'T CORRECTLY IMMERSE INTO THE GUIDES OF THE COLUMN AND THE RETAINING LOCK COULDN'T OPEN. WITH CONTINUED HEIGHT ADJUSTMENT, THE COLUMN LIFTED BOTH THE TABLE TOP AND THE UPPER PART OF THE TRANSPORTER TO THE EXTENT THAT THE SUPPORT FRAME WAS PULLED OUT OF ITS GUIDE. DURING THE SUBSEQUENT DOWNWARD MOVEMENT OF THE COLUMN (WITH THE TABLE TOP AND THE SUPPORT FRAME HANGING FROM IT), IT WASN'T POSSIBLE TO ALIGN THE GUIDING ELEMENTS OF THE CARRIER AND THE UPPER PART OF THE TRANSPORTER AGAIN. THE UPPER PART OF THE TRANSPORTER SAT OUTSIDE THE GUIDE ON THE CARRIER. WITH THE DOWNWARD MOVEMENT OF THE COLUMN, THE TABLE TOP, UNABLE TO ESCAPE THE TRANSPORTER, LIFTED OFF OF THE COLUMN AND BEGAN TILTING. THIS IS SUPPORTED BY THE OBSERVED DAMAGE. THE GUIDE ELEMENTS WERE DAMAGED AND THE CONNECTION BETWEEN THE UPPER PORTION OF THE TRANSPORTER AND THE PISTON ROD OF THE CYLINDER FOR HEIGHT ADJUSTMENT WAS BROKEN. THE UPPER PART OF THE TRANSPORTER WAS STILL STUCK ON THE TABLE TOP, WHICH WAS TRANSFERRED FROM THE COLUMN. THE COLUMN WILL BE REPAIRED. THE TRANSPORTER WAS EXCHANGED. MAQUET WAS INFORMED THAT BECAUSE THE TABLE LACKED THE OPTIONAL REMOTE CONTROL, THE TRANSFER WAS CONTROLLED BY THE WALL PANEL. FROM THIS DISTANCE, THE OPERATING ROOM STAFF MAY NOT BEEN AWARE OF WHAT WAS OCCURRING, PREVENTING ANY CORRECTIVE INTERVENTION DURING THE TABLETOP TRANSFER. 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. EXEMPTION#: (B)(4).

    Description of Event or Problem · 1

    DURING THE PREOPERATIVE TRANSFER OF THE EXTENSION TABLE TOP FROM THE TRANSPORTER TO THE COLUMN, THE UPPER PART OF THE TRANSPORTER WAS PULLED OUT OF THE GUIDING RAIL DURING THE UPWARDS MOVEMENT OF THE COLUMN. DURING THE SUBSEQUENT DOWNWARDS MOVEMENT OF THE COLUMN, THE TABLE TOP TILTED UPWARDS TO THE RIGHT FOOT SIDE. THE PT FELL ON THE FLOOR ON THE RIGHT-HAND SIDE. A COMPUTED TOMOGRAPHY SCAN OF THE PT WAS TAKEN TO CHECK FOR INJURIES. THE PT SUFFERED UNSPECIFIED FRACTURES AND THE HOSPITAL IS CONTINUING TO EVALUATE THE PT FOR NEUROLOGICAL INJURY. AT THE TIME OF THE EVENT, THE TABLE MOVEMENT WAS CONTROLLED AT THE WALL, NOT BY A CORDED CONTROLLER AT THE PEDESTAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET, O.R. TABLE SYSTEM 1120 TABLE, OPERATING-ROOM, AC-POWERED, FQO FQO MAQUET GMBH AND CO., KG. 1120.0500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O