BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 3868004 · Received May 9, 2014

    Report

    Report Number
    8020045-2014-00007
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER, SAMPLES OR OTHER FURTHER INFORMATION HAVE BEEN MADE AVAILABLE TO US SO FAR, NO ANALYSIS COULD BE PERFORMED. IT THEREFORE EVEN REMAINS UNCLEAR WHETHER THE CORRECT ELECTRODE (AND CONNECTOR) WAS CHOSEN FOR THE DEFIBRILLATOR USED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN. WE HAVE REQUESTED ADDITIONAL INFORMATION BUT NOT RECEIVED ANY YET. WE WILL CONTINUE OUR REQUESTS AND WILL RELAY ANY INFORMATION WE MIGHT RECEIVE AND FURTHER CONCLUSIONS IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED BY (B)(6) ABOUT AN INCIDENT WITH A DEFIBRILLATION ELECTRODE SET USED BY THE FIREBRIGADE (B)(6). A DEFIBRILLATION ELECTRODE SET (SKINTACT DF27N) AND AN UNKNOWN DEFIBRILLATOR WERE USED. THE INITIAL REPORT DISCLOSED THAT THE ELECTRODE CONNECTOR DID NOT FIT INTO THE DEFIBRILLATOR. TO THE DATE OF THIS REPORT, NO MORE PRECISE INFORMATION HAD BEEN MADE AVAILABLE DESPITE OF REPEATED REQUESTS. NO FURTHER INFORMATION ON THE PATIENT, THE PROCEDURE, THE DEFIBRILLATOR MODEL, A POSSIBLE PATIENT INJURY AND THE TREATMENT HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281528 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRO MKJ LEONHARD LANG GMBH DF27N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other