BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 8139471 · Received December 6, 2018

    Report

    Report Number
    1220908-2018-03537
    Event Type
    Death
    Date Received
    December 6, 2018
    Date of Event
    November 15, 2018
    Report Date
    November 15, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946006389
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING ADDITIONAL INFORMATION: THIS MDR WAS INADVERTENTLY SUBMITTED WITH THE INCORRECT DEVICE AND MANUFACTURER INFORMATION. THE CUSTOMER LATER REPORTED THAT THEY ARE NOT ALLEGING A MALFUNCTION OF THE X SERIES DEVICE USED IN THIS EVENT, RATHER THEY BELIEVE THE ISSUE WAS WITH THE ELECTRODE PADS (REFERENCE MFR REPORT# 1218058-2018-00115).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION AS IT RELATES TO THE MONITOR. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION INSTEAD THE CPR STAT PADS ADULT ELECTRODES WITH LOT NUMBER #1517 WAS RECEIVED UNOPENED IN ITS ORIGINAL PACKAGING. THESE ARE NOT THE EVENT ELECTRODES, BUT FROM THE SAME LOT AS THE ELECTRODES USED. INSPECTION OF PADS FOUND NO DISCREPANCIES. THE ELECTRODE PADS WERE SUBJECTED TO SEVERAL FUNCTIONALITY TESTS INCLUDING VARIOUS SHOCK DISCHARGES AT 30, 50, 100, 150, AND 200J. REVIEW OF DEVICE'S HISTORY LOG INDICATES A "DEFIB PAD LEAD FAULT MESSAGE" CONSISTENT WITH THE CUSTOMER REPORT. THERE WAS NO INDICATION THAT AN ATTEMPT WAS MADE TO DELIVER THERAPY. NO DEVICE ERRORS WERE OBSERVED AS PART OF THE REVIEW BUT WE DO OBSERVE THE DEVICE HAVING DIFFICULTY IDENTIFYING THE ELECTRODE SET. IDENTIFICATION DOES NOT IMPACT THE DEVICES ABILITY TO DELIVER THERAPY. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT, THE DEVICE DID NOT RECOGNIZE THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE AND ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 1

    PLEASE REFERENCE MEDWATCH REPORT 1218058-2018-00115 REGARDING THE PADS INVOLVED DURING THE SAME EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978380 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946006389

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death