BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 4999521 · Received August 11, 2015

    Report

    Report Number
    8020045-2015-00051
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    May 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE SAME LOT NUMBER WERE INSPECTED VISUALLY. NO FAULTS COULD BE DETECTED. THE RETURNED DEVICE SHOWED THE REPORTED PROBLEM. TWO STERNUM PRINTED PADS WERE ATTACHED TO THE SET. THE ELECTRODE SET CAME FROM A MANUAL ASSEMBLY LINE, WHERE THE ERROR WAS NOT DETECTED. AN ANALYSIS OF HISTORICAL DATA FROM THE LAST FIVE YEARS SHOWS TWO OTHER COMPLAINTS OF SIMILAR NATURE. DURING THIS PERIOD A TOTAL OF APPROXIMATELY (B)(6) COMPARABLE SETS HAS BEEN PRODUCED. WE ARE THEREFORE CONSIDERING THIS A VERY RARE EVENT CAUSED BY HUMAN ERROR. AS THE IFU STATES, " ALWAYS KEEP A SECOND PACK OF DEFIBRILLATION ELECTRODES W/THE DEFIBRILLATOR", A CORRECT SET WAS (AND WOULD HAVE BEEN) AVAILABLE AS WELL. IN ADDITION, THE INFO FOR TWO ALTERNATIVE PLACEMENT LOCATIONS IS ALSO PRINTED ON THE POUCH. WE THEREFORE ASSESS THE RISK RESULTING FROM THIS ERROR AS LOW. AN ONGOING PROJECT TO ADD AN AUTOMATED IMAGE PROCESSING CONTROL UNIT TO THIS LINE WILL BE PRIORITIZED TO PREVENT THE ERROR FROM REOCCURRING.

    Additional Manufacturer Narrative · 1

    WE HAVE SET UP ADDITIONAL MEASURES TO REDUCE THE LIKELIHOOD OF OCCURRENCE. THE APEX AND STERNUM PADS HAVE NOW DEFINED MARKED POSITIONS ON THE ASSEMBLY LINE. THE RIVETING OF APEX AND STERNUM PADS TO CABLES IS NOW PERFORMED ALWAYS IN THE SAME ORDER.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED ABOUT A MALFUNCTION W/A DEFIBRILLATION ELECTRODE AT (B)(6) HOSP. WHEN A POUCH OF A DEFIBRILLATION ELECTRODE SET WAS OPENED IN THE EMERGENCY DEPT., BOT PADS HAD THE "STERNUM" PRINT. THE STAFF OPENED OTHER SETS AND FOUND NO FURTHER FAULTY SET. THE INITIAL REPORTER ALSO STATED THAT THEY USED ANOTHER SET AND THER WAS NO DELAY IN CLINICAL TREATMENT. WE HAVE NOT RECEIVED ANY FURTHER INFO ABOUT THE PATIENT AND THE PROCEDURE PERFORMED SO FAR DESPITE OF REPEATED REQUESTS.

    Description of Event or Problem · 1

    AFTER REPEATED REQUESTS FOR MORE INFORMATION, OUR DISTRIBUTOR INFORMED US THAT NO FURTHER INFORMATION WOULD BE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526754 SKINTACT MKJ LEONHARD LANG GMBH DF27N 50421-0777

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other