BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 18606393 · Received January 30, 2024

    Report

    Report Number
    1220908-2024-00256
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Report Date
    January 9, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017538
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 B5 AND H6 (DEVICE PROBLEM CODE). THIS REPORT WAS INADVERTENTLY SUBMITTED. REPORTS OF THIS NATURE HAVE NO POTENTIAL FOR CLINICAL IMPACT. EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE LOGS. THE AUTOMATIC READINESS TEST WAS FAILING AND PROMPTING "NO ELECTRODE CONNECTED" AS THE CUSTOMER WAS USING PADS NOT CONFIGURED FOR THE TEST. THE TEST WAS CONFIGURED TO BE PERFORMED WITH CPR/MWP/COMPLETE AND THE CUSTOMER WAS USING ONESTEP BASE PEDIATRIC AND ONESTEP BASE ADULT PADS. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED CODE READINESS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043352 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017538

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown