BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRESPONDER TOURNIQUET

    MDR report key: 5043174 · Received August 31, 2015

    Report

    Report Number
    0009615387-2015-00004
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    March 1, 2015
    Report Date
    August 27, 2015
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE PYNG (B)(4).

    Description of Event or Problem · 1

    AN (B)(6) AMBULANCE PARAMEDIC TEAM RESPONDING TO A SEVERED LEG EMERGENCY COULD NOT GET THE MAT RESPONDER TOURNIQUET TO TIGHTEN. WHEN THEY TRIED TO TIGHTEN IT BY WINDING THE TENSION KEY, THE TOURNIQUET WAS NOT TIGHTENING. THEY ALSO FOUND THAT THEY COULD ONLY WIND IT ½ TURN OR NOT AT ALL. FROM THE INFORMATION THAT WAS RECEIVED TO DATE, THEY TRIED 3 DIFFERENT MATR'S AND NONE WORKED. PARAMEDICS USED A BELT FOR A TOURNIQUET TO OBTAIN OCCLUSION. SUBSEQUENTLY, AN EDUCATOR ALSO WITH NSW AMBULANCE DESCRIBED A SIMILAR EXPERIENCE WHEN TEACHING THE TOURNIQUET TO PARAMEDICS. SHE WAS UNABLE TO TIGHTEN THE UNIT. SHE PUT IT ASIDE AND OBTAINED ANOTHER UNIT. THIS WINDING KEY WAS ONLY ABLE TO BE TURNED A COUPLE OF TIMES BEFORE REACHING THE END. THE 3RD UNIT THAT SHE USED WAS IN THE EXPECTED "READY" POSITION (I.E., ALL THE WAY OUT) AND COULD BE USED CORRECTLY. FOLLOWING HER TRAINING SESSION SHE INVESTIGATED BOTH "FAULTY" UNITS AND FOUND THAT THEY WERE ALREADY WOUND IN. DURING HER EXAMINATION SHE FOUND THAT SHE COULD FULLY RELEASE (I.E., RESET) AND REUSE EACH UNIT. SHE THEN EXAMINED THE REMAINING UNOPENED UNIT WHILE STILL IN ITS PACKAGING AND UPON FEELING THROUGH THE PACKAGE SHE DISCOVERED THAT THEY WERE ALL AT DIFFERENT POINTS IN THE WINDING CYCLE. AS A RESULT NSW AMBULANCE SENT AN ADVISORY TO THEIR FIELD TO ENSURE THE TOURNIQUETS WERE IN THE PROPER CONFIGURATION AND, IF NOT, TO RESET THEM. ALL UNITS WERE FROM LOT NUMBER SL115802. ONE OF THE OPENED UNITS FROM THE EDUCATORS TRAINING SESSION AND THE 2 ADDITIONAL STOCK UNITS KNOWN TO BE IN DIFFERING STATES OF READINESS WERE RETURNED TO PYNG. PYNG'S INVESTIGATION OF THE RETURNED UNITS REVEALED ALL OF RETURNED UNITS WERE IN DIFFERENT STATES OF WINDING (I.E., NOT COMPLETELY IN THEIR "READY" POSITION). THE OPENED RETURNED UNIT WAS APPROXIMATELY 20% WOUND BUT IT IS UNLIKELY THIS IS THE ORIGINAL STATE OUT OF THE PACKAGE, THE SECOND UNIT (PACKAGED) WAS IN A COMPLETELY WOUND STATE AND THE THIRD UNIT (PACKAGED) WAS WOUND ABOUT HALF THE DISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575560 MATRESPONDER TOURNIQUET MATRESPONDER GAX PYNG MEDICAL CORP. MATR SL115802

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention