BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 14267728 · Received May 3, 2022

    Report

    Report Number
    8020045-2022-00010
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Report Date
    June 15, 2022
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531502912
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO THE DATE OF THIS REPORT. WE HAVE REQUESTED CUSTOMER SAMPLES FOR FURTHER INVESTIGATION. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FURTHER RESULTS.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO THE DATE OF THIS REPORT. WE HAVE REQUESTED CUSTOMER SAMPLES FOR FURTHER INVESTIGATION. DESPITE REPEATED REQUESTS NO FURTHER INFORMATION HAD BEEN MADE AVAILBLE TO US. OUR CUSTOMER INFORMED US THAT WE WILL HAVE NO MORE EXTRA INFORMATION FROM [THE USER]. IT IS THEREFORE UNCLEAR WHETHER A PATIENT WAS INJURED AT ALL AND WHETHER IT WAS JUST A COMPARATIVE TEST RUN BY THE CUSTOMER. THE INCIDENT WAS REPORTED BECAUSE IT IS UNKNOWN IF A REPORTABLE EVENT HAS HAPPENED AT ALL. THE INCIDENT MIGHT NOT CONSTITUTE A REPORTABLE EVENT. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE THEREFORE CONSIDER THE INVESTIGATION TO BE CLOSED.

    Description of Event or Problem · 0

    ON (B)(6), 2022, WE HAVE BEEN INFORMED ABOUT A POTENTIAL PRODUCT MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER PRESUMABLY IN (B)(6). SKINTACT DEFIBRILLATION ELECTRODES MODEL DF20NC AND A LIFEPAK 20E DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORTER SPECIFIED THAT "WE HAVE RECEIVED A COMPLAINT FOR PAD DF20NC LOT: 210720-4301. THAT WE HAVE JUST OFFER TO A NEW CLIENT AND THAT HE HAD JUST ORDERED FOR THE 1ST TIME. HIS FEEDBACK WAS SO. AFTER DIFFERENT TESTS MADE ON PATIENTS, THE USER HAD NOTICED THAT SKINTACT PADS DO NOT WORK AS WELL AS QUICK COMBO. THE USER NEED TO DO SEVERAL CHOCS AND INCREASE VOLTS TO GET AN OPTIMAL RESULT OR NO RESULT. THE CLIENT IS MORE SATISFY WITH QUICK COMBO PADS ON LIFEPAK 20E MODEL." NO FURTHER DETAILS HAVE BEEN SPECIFIED DESPITE REPEATED REQUESTS WHETHER A PATIENT WAS INJURED AT ALL AND WHETHER IT WAS JUST A COMPARATIVE TEST RUN BY THE CUSTOMER. THE INITIAL REPORTER HAS SPECIFIED IN A LATER COMMUNICATION THAT "I HAVE SEND A REMINDER TO OUR REGIONAL SALES MANAGER TO RUSH THE CLIENT. I WILL GET BACK TO YOU AS SOON AS I HAVE INFORMATION FROM THE CLIENT." WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FURTHER DETAILS AND WE MAY CAN REACH A CONCLUSION.

    Description of Event or Problem · 0

    ON APRIL 04TH, 2022, WE HAVE BEEN INFORMED ABOUT A POTENTIAL PRODUCT MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER PRESUMABLY IN FRANCE. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF20NC AND A LIFEPAK 20E DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORTER SPECIFIED THAT "WE HAVE RECEIVED A COMPLAINT FOR PAD DF20NC LOT: 210720-4301. THAT WE HAVE JUST OFFER TO A NEW CLIENT AND THAT HE HAD JUST ORDERED FOR THE 1ST TIME. HIS FEEDBACK WAS SO. AFTER DIFFERENT TESTS MADE ON PATIENTS, THE USER HAD NOTICED THAT SKINTACT PADS DO NOT WORK AS WELL AS QUICK COMBO. THE USER NEED TO DO SEVERAL CHOCS AND INCREASE VOLTS TO GET AN OPTIMAL RESULT OR NO RESULT. THE CLIENT IS MORE SATISFY WITH QUICK COMBO PADS ON LIFEPAK 20E MODEL." NO FURTHER DETAILS HAVE BEEN SPECIFIED DESPITE REPEATED REQUESTS WHETHER A PATIENT WAS INJURED AT ALL AND WHETHER IT WAS JUST A COMPARATIVE TEST RUN BY THE CUSTOMER. THE INITIAL REPORTER HAS SPECIFIED IN A LATER COMMUNICATION THAT "I HAVE SEND A REMINDER TO OUR REGIONAL SALES MANAGER TO RUSH THE CLIENT. I WILL GET BACK TO YOU AS SOON AS I HAVE INFORMATION FROM THE CLIENT." WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FURTHER DETAILS AND WE MAY CAN REACH A CONCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318641 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF20NC 210720-4301 19005531502912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other