BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID RESPONSE HUT TABLE

    MDR report key: 1612347 · Received February 11, 2010

    Report

    Report Number
    1932056-2010-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 10, 2010
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS EVENT, MEDICAL POSITIONING, INC. PERFORMED AN ANALYSIS OF ALL CUSTOMER-REPORTED PRODUCT EVENT DATA PERTAINING TO THE RAPID RESPONSE HUT TABLE. THE ANALYSIS INDICATED A REPETITIVE ISSUE MEDICAL POSITIONING, INC. HAS BEEN TRACKING WITH REGARD TO THE HEAD UP TILT MOTOR FUNCTION ON THIS PRODUCT. PREVIOUS REPORTS INDICATED THE MOTOR FAILED TO OPERATE, NORMALLY BEFORE THE BEGINNING OF A PROCEDURE, WITH THE TABLE IN A FLAT AND LEVEL POSITION EXHIBITING NO POTENTIAL FOR HARM. AS A RESULT OF THIS MOST RECENT EVENT, IT WAS DETERMINED THAT SINCE THIS ONE OCCURRED IN A HEAD-UP POSITION DURING A PROCEDURE, ALL CUSTOMERS USING ONE OF THE TABLES MANUFACTURED IN THE LOTS WE HAVE BEEN TRACKING SHOULD BE NOTIFIED. (B)(4). ON (B)(6) 2010, MEDICAL POSITIONING, INC. MAILED A CERTIFIED LETTER, WITH RETURN RECEIPT REQUESTED, TO EACH OF THESE CUSTOMERS INFORMING THEM WE HAVE IDENTIFIED A POTENTIAL PROBLEM THAT MAY EXIST IN SOME OF THE MOTORS AND ADVISED THEM TO "STOP USING THE TABLE IMMEDIATELY...". IN ADDITION, MEDICAL POSITIONING, INC. WILL BEGIN PLACING PHONE CALLS TO EACH CUSTOMER WHO HAS NOT RESPONDED TO THE LETTER ON MONDAY FEBRUARY 15, 2010 TO CONFIRM THE INFO WAS RECEIVED. TO CORRECT THE PROBLEM, MEDICAL POSITIONING INC'S ENGINEERING DEPARTMENT IS WORKING WITH THE ENGINEERING STAFF OF THE MOTOR MFR, SKF ACTUATION SYSTEMS, TO ISOLATE AND CORRECT THE ISSUE. ONCE THE PROBLEM IS ISOLATED AND CORRECTION IS THOROUGHLY TESTED, THE CORRECTION WILL BE FITTED ON EACH OF THE TABLES IN THE LIST PREVIOUSLY IDENTIFIED. THE CORRECTION WILL ALSO BE PART OF THE MFG PROCESS ON ALL NEW RAPID RESPONSE HUT TABLES PRODUCED.

    Description of Event or Problem · 1

    THE PRODUCT INVOLVED IN THIS EVENT WAS A RAPID RESPONSE HUT TABLE USED IN ELECTROPHYSIOLOGY STUDIES. AS IS NORMAL IN THESE PROCEDURES, THE PT WAS PLACED ON THE TABLE AND THE TABLE WAS TILTED TO 60 DEGREE OF HEAD-UP INCLINE. SOMETIME AFTER THE PROCEDURE HAD BEGUN THE PT BECAME UNRESPONSIVE AND THE STAFF DESIRED TO RETURN THE TABLE TO A LEVEL POSITION. TO DO THIS, A STAFF MEMBER PRESSED THE HEAD-DOWN BUTTON ON THE TABLE'S HAND WAND CONTROL AND THERE WAS NO RESPONSE FROM THE TABLE'S TILT MOTOR. THE STAFF PERSON THEN PRESSED THE EMERGENCY HEAD-DOWN TILT BUTTON AND AGAIN WAS NO RESPONSE FROM THE TABLE'S TILT MOTOR. THE STAFF MEMBER THEN PRESSED THE HOME BUTTON ON THE HAND WAND CONTROL (WHICH IS DESIGNED TO BRING THE TABLE TO A LEVEL POSITION) AND THERE WAS NO RESPONSE FROM THE TABLE'S TILT MOTOR. AT THIS POINT, THE STAFF CALLED A "CODE BLUE", AND 4 ADDITIONAL STAFF MEMBERS RESPONDED. THE STAFF MEMBERS SAFELY REMOVED THE PT FROM THE TABLE AND PLACED THE PT ON A GURNEY. ALMOST IMMEDIATELY UPON BEING PLACED ON THE GURNEY, THE PT BECAME RESPONSIVE. THE HOSPITAL STAFF MEMBER WHO REPORTED THE EVENT TO MEDICAL POSITIONING, INC. SAID THE PT SUFFERED NO IMMEDIATE OR ONGOING ILL EFFECTS FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RESPONSE HUT TABLE TILT TABLE LGX MEDICAL POSITIONING, INC. 1217

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other