BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21026811 · Received December 27, 2024

    Report

    Report Number
    1220908-2024-04627
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    November 30, 2024
    Report Date
    December 9, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946029517
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE DEVICE PERFORMED TO SPECIFICATION. A REVIEW OF THE DEVICE LOG INDICATES THE CUSTOMER WAS NOT IN THE CORRECT LEAD VIEW. THE USER ATTMPTED TO ACQUIRE ECG SIGNAL THROUGH THE 4-WIRE ECG LEADS BUT WERE UNABLE TO SEE THE ECG SIGNAL ON THE PATIENT DUE TO THE DEVICE REMAINING IN PAD VIEW WITH AN ECG PRESENT. THE DEVICE PASSED FUNCTIONAL TESTING. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511230 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2231111-01 NA 00847946029517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown