BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 5025551 · Received August 21, 2015

    Report

    Report Number
    8020045-2015-00053
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    April 17, 2015
    Report Date
    August 20, 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

    THE RETAINED SAMPLES HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM W/IN LIMITS. NO FAULTS COULD BE DETECTED. AS NO FURTHER INFO HAS BEEN PROVIDED TO US, DESPITE REPEATED REQUESTS, IT REMAINS UNCLEAR WHETHER THE DEFIBRILLATION ELECTRODE SET OR OTHER INFLUENCES HAVE BEEN RESPONSIBLE FOR THE INCIDENT. ON 08/11/2015, WE HAVE BEEN INFORMED BY A FIELD REP OF THE DISTRIBUTOR THAT HE HAD MANAGED TO GET THE ELECTRODES INVOLVED IN THE INCIDENT AFTER MEETING W/MEDICAL PHYSICS OF (B)(6) HOSPITAL. WE ARE STILL WAITING TO RECEIVE THE INVOLVED PRODUCTS FOR INVESTIGATION. WE WILL CONTINUE TO ASK FOR FURTHER INFORMATION AND WILL RELAY THIS AND THE RESULTS OF THE INVESTIGATION OF THE INVOLVED PRODUCTS IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE THREE SAMPLES INVOLVED IN THE INCIDENT WERE RETURNED AND TESTED WITH A MULTIMETER. THIS TEST INCLUDED ALL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. THEREBY NO DEVIATION WAS DETECTED. FOR TESTING THE FUNCTION OF THE RETURNED ELECTRODES A LIFEPACK 20E DEFIBRILLATOR WAS USED (SN: (B)(4)). THE CONNECTORS OF THE CABLE WERE PLUGGED INTO THE DEFIBRILLATOR WITHOUT ANY DIFFICULTY. ALL 3 ELECTRODE SETS WERE THEN APPLIED ON A DEFIBRILLATOR ANALYZER AND AN ECG READING WAS IMMEDIATELY OBTAINED. NO ISSUES COULD BE OBSERVED. THE COMPLAINED ISSUE COULD NOT BE REPEATED. THE TESTED DEVICES WERE FOUND TO PERFORM WITHIN LIMITS. WE HAVE BEEN REQUESTING THE MISSING INFORMATIONS FROM OUR CUSTOMER AND HAVE FINALLY RECEIVED A LETTER THAT THE INCIDENT IS CLOSED OUT: "(...) DUE TO THE FACT THIS HAPPENED SOME TIME AGO, THE CUSTOMER WOULD PREFER NOT OR CAN'T COMPLETE ALL THE INFORMATION ON THE FORM. WHAT HAS COME BACK REGARDING THE TESTING OF THE PADS, THE CLINICAL PHYSICS MANAGER IS SUSPICIOUS THAT IT MAY HAVE BEEN A USER ERROR, HENCE HE DOESN'T WISH TO HAVE THE COMPLAINT OPEN FOR SUCH A LONG TIME, THE CUSTOMER IS CONTINUING TO USE SKINTACT DF20NC." WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON JULY 22ND, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION W/A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL, (B)(6). THE DEFIBRILLATION ELECTRODE SET (SKINTACK DF20NC) WAS CONNECTED TO A PHYSIO CONTROL DEFIBRILLATOR (MODEL LIFEPAK 20). THE INITIAL REPORT DISCLOSED THE FOLLOWING INFO: "(...) CARDIAC ARREST - WHEN ATTEMPTING LIFEPAK 20, 3 SETS OF SKINTACK PADS FAILED TO WORK-NO TRACE PICK UP ON MACHINE - STAFF HAD TO USE OLDER DIFFERENT BRAND FROM STORE CUPBOARD. INJURY: NONE. INJURY DETAILS AND TREATMENT: NONE. ACTION: RESUSCITATION OFFICE ATTENDED- MEDICAL PHYSICS HAVE CHECKED OUT THE DEFIBRILLATOR AND FOUND NO ISSUES. (...)". NO FURTHER INFO ON THE PATIENT, THE PROCEDURE AND THE SKIN PREPARATION HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554557 SKINTACT MKJ LEONHARD LANG GMBH DF20NC 40702-0971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK