BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 9937604 · Received April 8, 2020

    Report

    Report Number
    8020045-2020-00006
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Report Date
    May 13, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS REPORTED THE INVOLVED DEVICE TO BE "DF20N LOT NO 200206-4044." INVESTIGATING THIS INFORMATION WE DETERMINED THAT NO DEFIBRILLATION ELECTRODES MODEL DF20N HAVE BEEN MANUFACTURED WITH LOT NUMBER 200206-4044. A PRODUCTION OF A DIFFERENT ELECTRODE MODEL WITH A CONNECTOR COMPATIBLE WITH A DIFFERENT DEFIBRILLATOR IS ASSOCIATED WITH THIS LOT NUMBER. WE HAVE REPEATEDLY REQUESTED FURTHER INFORMATION AND THE CONCERNED DEVICE BUT HAVE NOT RECEIVED ANY. THE DISTRIBUTOR AND INITIAL REPORTER HAS INFORMED US THAT THE CONCERNED DEVICE IS NOT AVAILABLE FOR AN INVESTIGATION. FURTHER ON WE HAVE BEEN INFORMED THAT IT IS NOT POSSIBLE TO IDENTIFY THE DEFIBRILLATOR MODEL THE CONCERNED ELECTRODE CAUSED PROBLEMS WITH BUT NO FURTHER INFORMATION WAS MADE AVAILABLE BY THE COMPLAINING HOSPITAL DESPITE REPEATED REQUESTS. BASED ON THE INFORMATION PROVIDED SO FAR, AN INVESTIGATION IS IMPOSSIBLE. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED MALFUNCTION. WE WILL THEREFORE CLOSE THE INVESTIGATION. .

    Description of Event or Problem · 0

    ON MARCH 16TH, 2020 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN HOSPITAL IN POLAND. SKINTACT DEFIBRILLATION ELECTRODES AND AN UNKNOWN DEFIBRILLATOR (MODEL UNKNOWN) HAD BEEN USED. THE INITIAL REPORT STATED "RE DF20N LOT NO 200206-4044. (...) THE (B)(6) HOSPITAL SENT BACK THIS ELECTRODE DUE TO THE CLIENT STATED THAT THIS ELECTRODE HAVE NOT A GOOD CONTACT. IT SEEMS THAT IT IS SOMETHING WRONG IN THE PLUG. THEY USE WITH THE SAME DEFIBRILLATOR ELECTRODE PRODUCED BY COVIDIEN AND EVERYTHING IS OK." NO INFORMATION WAS PROVIDED IF A PATIENT WAS HARMED CAUSED BY THE MALFUNCTION, WHICH DEFIBRILLATOR MODEL WAS USED AND IF THE INVOLVED SAMPLE IS AVAILABLE FOR A FURTHER TESTING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS REPORTED THE INVOLVED DEVICE TO BE "DF20N LOT NO 200206-4044". INVESTIGATING THIS INFORMATION WE DETERMINED THAT NO DEFIBRILLATION ELECTRODES MODEL DF20N HAVE BEEN MANUFACTURED WITH LOT NUMBER 200206-4044. A PRODUCTION OF A DIFFERENT ELECTRODE MODEL WITH A CONNECTOR COMPATIBLE WITH A DIFFERENT DEFIBRILLATOR IS ASSOCIATED WITH THIS LOT NUMBER. WE HAVE REPEATEDLY REQUESTED CLARIFICATION FROM THE INITIAL REPORTER AND THE DEVICE INVOLVED (SUPPOSEDLY RETURNED BY THE HOSPITAL) BUT AS OF TODAY NOT RECEIVED ANY ANSWER. BASED ON THE INFORMATION PROVIDED SO FAR, AN INVESTIGATION IS IMPOSSIBLE. WE WILL CONTINUE TO REQUEST THE MISSING INFORMATION AND PROVIDE A FOLLOW UP REPORT ONCE WE WILL RECEIVE IT.

    Description of Event or Problem · 1

    ON MARCH 16TH, 2020 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN HOSPITAL IN (B)(6). SKINTACT DEFIBRILLATION ELECTRODES AND AN UNKNOWN DEFIBRILLATOR (MODEL UNKNOWN) HAD BEEN USED. THE INITIAL REPORT STATED "RE DF20N LOT NO 200206-4044. (...) THE BIG PUBLIC HOSPITAL SENT BACK THIS ELECTRODE DUE TO THE CLIENT STATED THAT THIS ELECTRODE HAVE NOT A GOOD CONTACT. IT SEEMS THAT IT IS SOMETHING WRONG IN THE PLUG. THEY USE WITH THE SAME DEFIBRILLATOR ELECTRODE PRODUCED BY COVIDIEN AND EVERYTHING IS OK." NO INFORMATION WAS PROVIDED IF A PATIENT WAS HARMED CAUSED BY THE MALFUNCTION, WHICH DEFIBRILLATOR MODEL WAS USED AND IF THE INVOLVED SAMPLE IS AVAILABLE FOR A FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402363 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other