BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 11126930 · Received January 6, 2021

    Report

    Report Number
    1220908-2021-00011
    Event Type
    Death
    Date Received
    January 6, 2021
    Date of Event
    December 20, 2020
    Report Date
    December 24, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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 SECTION B1, B2, B5, H1, AND H6 (HEALTH EFFECT CLINICAL CODE & HEALTH EFFECT IMPACT CODE). EVALUATION RESULTS: THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DATA FILE OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE DATA FILE SHOWS THAT A SIGNAL FROM THE ELECTRODES WAS IDENTIFIED AND CAPABLE OF DISPLAYING WHEN ATTACHED. HOWEVER, THE END USER NEVER CHANGED THE LEAD VIEW TO THE PADS LEAD VIEW. HAD THE LEAD VIEW BEEN CHANGED, THE DEVICE WOULD HAVE DISPLAYED THE ECG SIGNAL. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    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.

    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 DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19447 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death