BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 11072340 · Received December 24, 2020

    Report

    Report Number
    1220908-2020-04172
    Event Type
    Death
    Date Received
    December 24, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS SHOWED NO EVIDENCE OF ANY ECG SIGNAL PROBLEMS THROUGH LEAD OR PADS. TWO SETS OF ELECTRODE PADS WERE RECEIVED. ONE SET OF PEDI PADS THAT WERE OPENED AND ADULT PADS THAT WERE STILL SEALED IN THE PACKAGE. THE UNOPENED ADULT STAT PADS ARE EXPECTED TO PROVIDE NO SIGNAL AND A POOR PAD CONTACT MESSAGE, AS THERE IS NO SHORTING WIRE. THE OPENED SET OF PEDI PADS WERE TESTED AND WERE CAPABLE OF ACQUIRING AN ECG SIGNAL AND DELIVERING ENERGY. IT IS SUSPECTED THAT THE ADULT STAT PADS WITH NO SHORTING WIRE MAY HAVE CAUSED CONFUSION FOR THE USERS AND THIS CUSTOMER MAY REQUIRE ADDITIONAL EDUCATION AND TRAINING. ANALYSIS OF 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 ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536259 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1 Death