BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID RESPONSE HUT

    MDR report key: 5249784 · Received November 20, 2015

    Report

    Report Number
    1932056-2015-00002
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    July 1, 2015
    Report Date
    October 27, 2015
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(6) 2014, THE USER FACILITY REPORTED TO MPI THAT THEY HAD BROKEN THEIR TILT ANGLE SELECTOR SWITCH AND HAND-CONTROL AND WERE LOOKING TO REPLACE THOSE PARTS. THE TILT ANGLE SELECTOR SWITCH WAS DAMAGED WHILE TRANSPORTING THE TABLE AND THE HAND-CONTROL HAD BEEN DROPPED AND BROKEN. MPI PROVIDED THE USER FACILITY WITH PART INFO NECESSARY TO REPLACE THE BROKEN COMPONENTS, AND THE FACILITY ORDERED THOSE PARTS IN (B)(6) 2014. MPI DIDN'T HEAR FROM THE FACILITY AGAIN UNTIL (B)(6) 2015 WHEN IT WAS REPORTED THE TABLE WASN'T RESPONDING TO COMMANDS FROM THE HAND-CONTROL. MPI WORKED WITH THE FACILITY'S BIOMED STAFF IN AN EFFORT TO DIAGNOSE THE ISSUE. HOWEVER, BIOMED TESTING OVER A DAY AND A HALF PERIOD REVEALED THAT THE ISSUE COULD NOT BE RECREATED. BIOMED TESTED EVERY FUNCTION ON THE HAND-CONTROL AND CONFIRMED THE TABLE RESPONDED CORRECTLY EVERY TIME. IT WAS DETERMINED THE ISSUE WAS FROM USER MISUNDERSTANDING OF THE PRODUCT. BIOMED STAFF AGREED. IN A F/U APPROX ONE MONTH LATER, BIOMED STAFF AT THE FACILITY CONFIRMED THE TABLE HAD EXPERIENCED NO FURTHER ISSUES. MPI CLOSED ITS INTERNAL CASE ACCORDINGLY ON (B)(6) 2015. ON (B)(6) 2015, A DIFFERENT BIOMED STAFF MEMBER FROM THE USER FACILITY CALLED MPI ASKING FOR CLARIFICATION OF THE (B)(6) ISSUE SO THAT THEY COULD CLOSE THE MATTER ON THEIR END. MPI EXPLAINED THAT THE ISSUE WAS DEEMED TO BE SIMPLY A MISUNDERSTANDING BECAUSE THE ISSUE COULD NOT BE RECREATED AT THAT TIME. HOWEVER, THE USER FACILITY NOW CLAIMED THAT THEY WERE CONTINUING TO HAVE ISSUES. A PHONE CONFERENCE WAS HELD WITH THE FACILITY THE FOLLOWING DAY, (B)(6) 2015 TO WALK THEIR BIOMED STAFF THROUGH SOME TEST PROCEDURES AND TO IDENTIFY ANY ISSUES. BASED ON THAT PHONE CONVERSATION, IT WAS NOT APPARENT TO MPI THAT THERE WERE ANY ISSUES. ANYTHING TO THE CONTRARY WAS NOT ACCURATELY ARTICULATED TO MPI. BIOMED STATED THEY WOULD SEND A VIDEO SHOWING THE TABLE IN OPERATION, BUT NO VIDEO WAS EVER RECEIVED BY MPI. IN ADDITION, MPI BECAME AWARE THAT THE USER FACILITY HAD BEEN PLUGGING AND UNPLUGGING THE TABLE WITHOUT FIRST ENSURING THE POWER SWITCH WAS TURNED "OFF". THE FACILITY WAS ADVISED AGAINST EMPLOYING THIS PRACTICE AND WAS REMINDED THAT THE USER MANUAL, AS WELL AS A TAG LOCATED ON THE POWER CORD ITSELF, WARNS THAT THE POWER MUST BE TURNED OFF PRIOR TO PLUGGING THE TABLE. MPI THEN RECEIVED NOTICE OF THE MDR FILED BY THE USER FACILITY ON (B)(6) 2015. MPI SUBSEQUENTLY SENT A TECH TO TEST THE TABLE ON-SITE AT THE FACILITY. UPON ARRIVAL, THE TECH FOUND THE PRODUCT WAS UNPLUGGED, BUT THE POWER SWITCH WAS STILL IN THE "ON" POSITION, INDICATING THAT THE TABLE IS CONTINUING TO BE PLUGGED AND UNPLUGGED WITHOUT FIRST SWITCHING THE POWER OFF. DURING THE TEST, THE TABLE FAILED TO RESPOND ACCURATELY TO A COUPLE OF COMMANDS AND THE BRAKE MECHANISM ATTEMPTED TO ENGAGE BY ITSELF WHILE PERFORMING SOME OPERATIONS. THESE ARE SYMPTOMS OF A MALFUNCTIONING AV CONTROL BOX. WHILE IT WOULD BE IMPOSSIBLE TO IDENTIFY ANY SINGLE ISSUE OR EVENT THAT CAUSED THE LINEAR REGULATOR TO FAIL, MPI BELIEVES THE CASE HISTORY SHOWS THAT USER ABUSE IT THE LIKELY ROOT CAUSE OF THIS PARTICULAR FAILURE. DAMAGED ELECTRICAL COMPONENTS, SUCH AS THE TILT ANGLE SELECTOR AND HAND-CONTROL REPLACED IN 2014, OR THE PRACTICE OF CONNECTING THE DEVICE TO ELECTRICAL POWER WITHOUT FIRST TURNING THE POWER OFF, CAN CAUSE DAMAGE TO THE LINEAR REGULATOR IN THE AV CONTROL BOX BY EXPOSING IT TO MORE POWER THAN IT CAN HANDLE. ULTIMATELY, THIS CAN LEAD TO THE COMMAND RESPONSE ISSUES REPORTED BY THE FACILITY. THE USER FACILITY HAS BEEN MADE AWARE OF THE EVAL RESULTS AND REMINDED TO ENSURE THE POWER IS TURNED OFF PRIOR TO CONNECTING THE DEVICE TO ELECTRICAL POWER. THE FACILITY WAS ALSO PROVIDED INFO FOR WHICH PARTS TO REPLACE TO RESOLVE THE ISSUE, SHOULD THEY CHOOSE TO DO SO. ONCE THE PARTS ARE REPLACED, MPI WOULD THEN F/U TO ENSURE THE TABLE IS WORKING PROPERLY. MPI WILL CONTINUE TO MONITOR THIS MATTER AND WILL PROVIDE F/U INFO IN THE EVENT NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, MEDICAL POSITIONING, INC. (MPI) RECEIVED A COPY OF THE MDR SUBMITTED BY MISSION VIEJO FROM (B)(6) 2015. THE REPORT STATED THAT THE FACILITY WAS "PERFORMING A TILT TABLE TEST. PT PASSED OUT AND THE TILT TABLE WOULD NOT GO DOWN TO SUPINE POSITION. RED EMERGENCY BUTTON WOULD NOT WORK NOR DID THE DOWN BUTTON OF THE TABLE CONTROL PANEL. PT WAS BEGINNING TO SEIZE WHEN MANUALLY PULLING THE TABLE TO SUPINE POSITION." AFTER COMMUNICATING WITH THE USER FACILITY, MPI SENT A TECH TO PUT THE TABLE THROUGH A COMPREHENSIVE TEST AND WAS ABLE TO RECREATE THE ISSUE AS DESCRIBED, WHICH IS THE RESULT OF A DAMAGED AV CONTROL BOX. THE ROOT CAUSE OF THE DAMAGE APPEARS STEM FROM USER ABUSE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770382 RAPID RESPONSE HUT RR HUT LGX MEDICAL POSITIONING, INC. 1017

    Patients

    Seq Age Sex Outcome Treatment
    1