BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 16218396 · Received January 20, 2023

    Report

    Report Number
    1220908-2023-00125
    Event Type
    Death
    Date Received
    January 20, 2023
    Date of Event
    December 24, 2022
    Report Date
    December 30, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. PLEASE REFERENCE SECTIONS A2, B1, B2, B5, B7, H1 AND H6 (HEALTH EFFECT CLINICAL/HEALTH EFFECT IMPACT CODES). EVALUATION RESULTS: THE ZOLL R SERIES WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION AND WAS OPERATING TO SPECIFICATION. ZOLL INVESTIGATION DETERMINED THAT THE ZOLL ELECTRODES WERE BEING USED OFF LABEL WITH A LUCAS DEVICE FROM ANOTHER MANUFACTURER. THE ZOLL CPR PUCK IS DESIGNED FOR MANUAL CPR, BUT IN THIS CASE THE LUCAS DEVICE WAS USED ON TOP OF THE CPR PUCK. REVIEW OF THE CLINICAL LOG FILE SHOWS MULTIPLE PADS OFF MESSAGES AS WELL AS RAPID CHANGING OF PADS ON AND PADS OFF MESSAGES OCCURING WHILE CPR IS BEING PERFORMED WITH THE LUCAS AUTOMATED CPR DEVICE. THIS LOSS OF COUPLING IMPACTED THE DEVICE'S ABILITY TO VIEW ECG VIA THE ELECTRODE PADS. THE LUCAS CPR DEVICE HAS NOT BEEN VALIDATED FOR USE WITH ZOLL PRODUCTS. THE LUCAS IFU STATES "ONLY USE JOLIFE AB-APPROVED ACCESSORIES WITH THE LUCAS CHEST COMPRESSION SYSTEM. THE LUCAS DEVICE MAY NOT OPERATE CORRECTLY IF YOU USE UNAPPROVED ACCESSORIES." THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A MALE PATIENT (AGE UNKNOWN), THE DEVICE DISPLAYED A ''PAD ON / PADS OFF" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A MALE PATIENT (AGE UNKNOWN), THE DEVICE DISPLAYED A ''PAD ON / PADS OFF" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006007 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death