BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 22095817 · Received May 28, 2025

    Report

    Report Number
    1220908-2025-02045
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017200
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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 SECTION 5B AND H6 (MEDICAL DEVICE PROBLEM CODE) UPDATED. THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. HOWEVER, THE CUSTOMER PROVIDED THE DATA FILE FOR REVIEW. IT WAS REPORTED THAT THE UNIT ALARMED "CHECK PADS" DURING BOVIE ACTIVATION, RAISING CONCERNS ABOUT POTENTIAL QRS TONE LOSS. ANALYSIS SHOWED THE QRS DETECTION WAS IMPACTED BY SIGNAL COMPLEXITY AND ELECTRICAL NOISE. THE ISSUE WAS DUE TO A KNOWN BEHAVIOR CALLED QRS DETECTION BLANKING, WHERE THE DEVICE TEMPORARILY SUSPENDS DETECTION TO AVOID FALSE POSITIVES CAUSED BY NOISE OR INTERFERENCE FROM ELECTROSURGICAL EQUIPMENT. IN THIS CASE, THE BLANKING INTERVAL EXTENDED FROM 40 MILLISECONDS TO 160 MILLISECONDS DUE TO HIGH NOISE LEVELS. THE DEVICE OPERATED AS EXPECTED. THERE WAS NO FAULT FOUND WITH THE DEVICE. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    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 ATTEMPTING TO MONITOR A 79-YEAR-OLD FEMALE PATIENT USING THE BOVIE, CLINICAL STAFF REPORTED INTERMITTENT QRS TONE/DROPOUT AND INCONSISTENT R-WAVE SENSING AND THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A 79-YEAR-OLD FEMALE PATIENT USING THE BOVIE, THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013963 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001000301110012 NA 00847946017200

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female