BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 10488445 · Received September 3, 2020

    Report

    Report Number
    1220908-2020-02775
    Event Type
    Injury
    Date Received
    September 3, 2020
    Report Date
    August 14, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017521
    PMA / PMN Number
    K060559/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTION B5 AND H6 (PATIENT CODE). EVALUATION: THE DEVICE AND MULTIFUNCTION CABLE FROM THE EVENT WERE RETURNED TO ZOLL MEDICAL CORPORATION. THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE AND MULTIFUNCTION CABLE WERE PUT THROUGH EXTENSIVE TESTING INCLUDING SHOCK TESTING AND DEIB CYCLING WITHOUT DUPLICATING A MALFUNCTION. THE REPORTED EVENT DATES RANGED FROM (B)(6) 2020, HOWEVER, THE EARLIEST DATE IN THE LOG IS (B)(6) 2020. AS A RESULT, ANY EVENTS PRIOR TO (B)(6) 2020 CANNOT BE CONFIRMED. ALL SHOCK EVENTS BETWEEN (B)(6) 2020 FOUND NO DISCREPANCIES WITH IMPEDANCE OR ENERGY DELIVERED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE PADS FROM THE REPORTED EVENT WERE DISCARDED AND WERE NOT RETURNED FOR EVALUATION. IT IS IMPORTANT TO NOTE THAT THE CUSTOMER CONFIRMED USING NON-ZOLL PADS, CARDIOCLEAR RADIOLUCENT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A FIRST DEGREE BURN AND WAS TREATED WITH A TOPICAL OINTMENT. PLEASE REFERENCE MED WATCH REPORTS 1220908-2020-02774, 1220908-2020-02776 AND 1220908-2020-02777 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A BURN. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE DEGREE OF THE BURN. PLEASE REFERENCE MED WATCH REPORTS 1220908-2020-02774, 1220908-2020-02776 AND 1220908-2020-02777 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953688 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other