BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 11348606 · Received February 19, 2021

    Report

    Report Number
    1220908-2021-00522
    Event Type
    Death
    Date Received
    February 19, 2021
    Date of Event
    November 21, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE LOG INDICATED THE DEVICE WAS IN LEAD II AND LEAD III FOR THE FIRST 15 MINUTES OF THE CASE. IT WAS NOT UNTIL AFTER THE DEVICE WENT INTO RESCUE PROTOCOL THAT THE DEVICE DISPLAYED ECG VIA PADS. ONCE THE LEAD VIEW WAS CHANGED TO PADS,THE ECG SIGNAL WAS DISPLAYED FOR THE REMAINDER OF THE CASE. THE DEVICE PERFORMED AS DESIGNED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED 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
    244553 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death