BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 14489359 · Received May 24, 2022

    Report

    Report Number
    1220908-2022-01826
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Report Date
    May 3, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017163
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION. THE CUSTOMER HAS BEEN INFORMED THAT THE DEVICE WILL PROMPT "CHECK PADS" DURING BOVIE DUE TO THE INTERFERENCE CAUSED BY ELECTROSURGICAL UNITS.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217425 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown