BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 9512982 · Received December 23, 2019

    Report

    Report Number
    1220908-2019-03881
    Event Type
    Death
    Date Received
    December 23, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946099381
    PMA / PMN Number
    K011541/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, A CLINICAL DATA FILE FROM THE REPORTED INCIDENT WAS PROVIDED FOR REVIEW. REVIEW OF THE CLINICAL DATA FILE INDICATED THAT FIVE OUT OF EIGHT ANALYSIS EVENTS PERFORMED DID NOT MEET THE CRITERIA FOR A SHOCKABLE EVENT DUE TO THE ECG BEING BELOW ONE HUNDRED MICROVOLTS OR PRESENCE OF MOTION ARTIFACTS CAUSED BY CPR COMPRESSIONS DURING AN ANALYSIS. AFTER REVIEW, IT WAS CONCLUDED THAT THE DEVICE WORKED AS DESIGNED AND CONFIGURED AND WITHIN THE LIMITATIONS OF THE TECHNOLOGY AVAILABLE. THIS CLAIM HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR-OLD MALE PATIENT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308227 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA 00847946099381

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death