BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 9527516 · Received December 27, 2019

    Report

    Report Number
    1220908-2019-04155
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    December 16, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND ELECTRODE PADS WERE RETURNED TO ZOLL MEDICAL CORPORATION AND PERFORMED AS EXPECTED. THE DEVICE WAS PUT THROUGH EXTENSIVE TROUBLE SHOOTING WHICH INCLUDED BENCH HANDLING, DEFIB AND PACE FUNCTIONAL TESTING, AND IMPEDANCE CHECK WITHOUT DUPLICATING THE REPORT. THE PROVIDED PICTURES WERE REVIEWED AND CONFIRMED THE BURN. THE PICTURES INDICATED THAT THE PADS WERE APPLIED OVER A SET OF MONITORING ELECTRODES AND ANOTHER SET THAT WAS PLACED ON THE FOLD OF THE PATIENT'S BREAST RATHER THAN UNDERNEATH. THE INSTRUCTION FOR USE PROVIDED DIAGRAMS, SPECIFIC INSTRUCTIONS ON GOOD PLACEMENT AND WARNS AGAINST PLACING THE PADS ON FOLDS OF SKIN OR OVER MONITORING ELECTRODES. ELECTRODE LABELING ALSO PROVIDE INSTRUCTIONS FOR PROPER ELECTRODE APPLICATION TECHNIQUE. POOR ADHERENCE AND/OR AIR UNDER THE ELECTRODES CAN LEAD TO POSSIBILITY OF ARCING AND SKIN BURNS. GOOD SKIN PREPARATION DOES NOT GUARANTEE A BURN WILL NOT OCCUR AND BURNS FROM DEFIBRILLATION IS AN EXPECTED RISK. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A SERIOUS INJURY. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE SEVERITY OF BURNS SUSTAINED BY THE PATIENT. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1220908-2019-04156 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317112 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other