BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAIN ASSEMBLY, BLS, ZOLL AED 3, JAPANESE JRC

    MDR report key: 21841749 · Received April 15, 2025

    Report

    Report Number
    1220908-2025-01306
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 24, 2025
    Report Date
    March 25, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 SECTIONS B5 AND H6 (MEDICAL DEVICE PROBLEM CODE). THE DEVICE WAS RETURNED TO ZOLL JAPAN FOR EVALUATION. FOR THE CUSTOMER'S REPORT OF SHOCK ADVISED FOR A NON-SHOCKABLE RHYTHM, THE DEVICE PERFORMED TO SPECIFICATION. THE DEFIBRILLATOR'S ALGORITHM ANALYZES ECG IN THREE SEGMENTS AND ADVISES A SHOCK IF AT LEAST TWO SHOW A SHOCKABLE RHYTHM. IN ONE CASE, A 120 JOULE SHOCK WAS DELIVERED DUE TO MOTION ARTIFACTS, LIKELY CAUSED BY PATIENT MOVEMENT, WHICH DISTORTED THE ECG AND LED TO INCORRECTLY INTERPRETING THE RHYTHM AS SHOCKABLE. FOR THE CUSTOMER'S REPORT OF UNIT SHUTS OFF, THE ISSUE WAS NOT REPLICATED OR CONFIRMED. THE DEVICE CORRECTLY ISSUED A LOW BATTERY ALERT, AND NO SIGNS OF PREMATURE BATTERY FAILURE WERE FOUND. THE DEVICE PASSED FUNCTIONAL TESTING. THE CUSTOMER WAS ADVISED TO REPLACE THE BATTERY. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

    INTERNATIONAL: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A PATIENT (AGE & GENDER UNKNOWN) WHOSE RIGOR MORTIS HAD ALREADY BEGUN, THE DEVICE ADVISED A SHOCK FOR THE RHYTHM THAT WAS BELIEVED TO BE NON-SHOCKABLE AND THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A PATIENT (AGE & GENDER UNKNOWN) WHOSE RIGOR MORTIS HAD ALREADY BEGUN, THE DEVICE ADVISED A SHOCK FOR THE RHYTHM THAT WAS BELIEVED TO BE NON-SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114453 MAIN ASSEMBLY, BLS, ZOLL AED 3, JAPANESE JRC DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1128-001203-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown