BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR STAT PADZ HVP MULTI-FUNCTION

    MDR report key: 8228918 · Received January 8, 2019

    Report

    Report Number
    1218058-2018-00115
    Event Type
    Death
    Date Received
    January 8, 2019
    Date of Event
    November 15, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT ELECTRODES WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE CPR STAT PADZ ADULT ELECTRODES WITH THE SAME LOT NUMBER AS THE EVENT ELECTRODES (#1517) WAS RECEIVED UNOPENED IN ITS ORIGINAL PACKAGING. INSPECTION OF THE 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 THE ASSOCIATED 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 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 FAILED TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN WAITED FOR ANOTHER AMBULANCE TO OBTAIN ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18180 CPR STAT PADZ HVP MULTI-FUNCTION ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-0402 1517 00847946016319

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death