BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES

    MDR report key: 21322603 · Received February 6, 2025

    Report

    Report Number
    1220908-2025-00409
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 15, 2025
    Report Date
    January 16, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017521
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    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 SECTIONS A2, A3, B5, B7 AND H6 (HEALTH EFFECT CLINICAL CODE, DEVICE PROBLEM CODE, HEALTH EFFECT IMPACT CODE). THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. TO DATE, ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE, ELECTRODES, DEVICE LOGS, OR PHOTOS FROM THE INCIDENT. THE CUSTOMER WAS UNABLE TO CONFIRM IF PROPER SKIN PREPERATION WAS PERFORMED. THE R SERIES ALS OPERATOR'S GUIDE (9650-0912-01 REV. YA) WARNS THE USER THAT EXCESSIVE HAIR, POOR ADHERENCE AND/OR AIR UNDER THE ELECTRODES, AS WELL AS DAMAGE/FOLDING IN THE ELECTRODE PACKAGING CAN LEAD TO THE POSSIBILITY OF ARCING AND SKIN BURNS. IT IS IMPORTANT TO NOTE THAT THE PADS USED DURING THE EVENT WERE CONMEWD PADPRO RADIOTRANSPARENT ELECTODES. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PATIENT RECEIVED BURN(S) OF AN UNKNOWN DEGREE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE SEVERITY OF THE BURN(S) OR ADDITIONAL TREATMENT THE PATIENT RECEIVED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 53-YEAR-OLD MALE PATIENT, AN ARC WAS SEEN FROM THE ELECTRODE PADS (CONMED PADPRO RADIOTRANSPARENT ELECTRODES P/N 2001Z-PC). COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION PLEASE REFERENCE MEDWATCH REPORT NUMBER 1220908-2025-00410 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909792 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001005201310012 NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other