BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET, MOBILE OPERATING TABLE ALPHAMAXX

    MDR report key: 3766624 · Received April 11, 2014

    Report

    Report Number
    8010652-2014-00010
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MAQUET GMBH AND CO. KG
    Product Code
    FQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) INVESTIGATED THE DEVICE AND FOUND A DEFECTIVE SENSOR. AS RESULT OF THIS MALFUNCTION, CONTROL OF THE TABLE VIA HAND CONTROL WAS NOT POSSIBLE. THE ALPHAMAXX OR TABLE IS EQUIPPED WITH AN OVERRIDE PANEL INTEGRATED INTO THE COLUMN OF THE TABLE. THIS PANEL SUPERSEDES ANY EXTERNAL CONTROL DEVICE AND PER THE INSTRUCTIONS FOR USE ((B)(4)) IS TO BE USED IF THE TABLE FAILS TO RESPOND TO THE COMMANDS OF THE HAND CONTROL UNIT. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE PT INTUBATED, THE PATIENT REFLUXED AND STOMACH ACID CAME UP INTO THE TUBE. THE OPERATING NURSE ATTEMPTED TO MOVE THE MAQUET OPERATING TABLE INTO TRENDELENBURG POSITION TO AVOID ACID IN THE PATIENT'S LUNGS. THE TABLE DID NOT RESPOND TO THE HAND CONTROL AND AN ERROR CODE WAS DISPLAYED ON THE HAD CONTROL UNIT. AFTER AN EXTENDED DELAY, THE OPERATING ROOM STAFF WAS ABLE TO REPOSITION THE TABLE, USING THE OVERRIDE CONTROL PANEL BUILT INTO THE TABLE. THE PT WAS DIAGNOSED WITH PNEUMONIA AFTER THIS EVENT. MFR REFERENCE #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221587 MAQUET, MOBILE OPERATING TABLE ALPHAMAXX TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH AND CO. KG 1133.22B1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization