BEUDAMED
    FDA Adverse Event Summary report: N

    RAPID RESPONSE HUT TABLE

    MDR report key: 3246713 · Received July 15, 2013

    Report

    Report Number
    1932056-2013-00002
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT PASSED ALL OF MEDICAL POSITIONING'S PRODUCT RELEASE SAFETY INSPECTIONS AND OPERATED TO SPEC BEFORE BEING PACKAGED AND SHIPPED TO THE CUSTOMER. UPON INSPECTION AND INVESTIGATION, AFTER THE INCIDENT TOOK PLACE, IT WAS FOUND THAT THE END USER DID NOT FOLLOW ESSENTIAL LABELING PRESENT BOTH ON THE DEVICE AND IN THE PRODUCTS MANUAL. SPECIFICALLY, THE END USER DID NOT FOLLOW AN IMPORTANT ELECTRICAL WARNING WHICH STATES, "PRIOR TO CONNECTING THE PRODUCT TO ELECTRICAL POWER, CHECK TO MAKE SURE THE POWER SWITCH LOCATED ON THE LOWER POWER BOX IS IN THE "OFF" POSITION." INSPECTION OF THE PRODUCT SHOWED THAT THE WARNING LABEL WAS INTACT AND PROPERLY LOCATED ON THE PRODUCT (ATTACHED TO THE POWER CORD) AND IN THE USER INSTRUCTIONS. WHILE WE CONTINUE TO INVESTIGATE THE AFFECTED COMPONENTS, THE PRELIMINARY RESULTS INDICATE THAT THE ACT OF REPEATEDLY PLUGGING THE PRODUCT INTO AN ELECTRICAL RECEPTACLE WITH THE POWER SWITCH IN THE "ON" POSITION MAY HAVE DAMAGED THE CONTROL ELECTRONICS.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A SYNCOPE TEST. THE PT WAS PLACED INTO 70 DEGREE REVERSE TRENDELENBURG (HEAD-UP POSITION) ON A MEDICAL POSITIONING, INC RAPID RESPONSE HUT TABLE. AS SYMPTOMS OF SYNCOPE PRESENTED, THE NURSE ATTEMPTED TO MOVE THE PT TO A LEVEL POSITION BY PRESSING THE EMERGENCY DOWN BUTTON ON THE PRODUCT'S HAND SWITCH. THE TABLE DID NOT MOVE SO THE NURSE PRESSED THE HEAD DOWN BUTTON WHICH DIDN'T WORK EITHER. AFTER 1 MINUTE, THE PT WAS MANUALLY REMOVED FROM THE PRODUCT AND PLACED ON THE FLOOR. THE PT HAD LOST VITALS AND WAS REVIVED. ONCE STABILIZED, THE PT WAS ADMITTED INTO THE HOSPITAL, SO SHE COULD RECEIVE A PACEMAKER. DURING OUR INVESTIGATION, THE NURSE STATED THAT THE TABLE HAD BEEN "TEMPERAMENTAL" FOR A WHILE, HOWEVER, THE CUSTOMER DID NOT REPORT A COMPLAINT ON THE PRODUCT UNTIL NOW PER CUSTOMER AND MEDICAL POSITIONING, INC RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327766 RAPID RESPONSE HUT TABLE RAPID RESPONSE HUT TABLE LGX MEDICAL POSITIONING, INC. 1217

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R