BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8900-0224-01

    MDR report key: 19248651 · Received May 6, 2024

    Report

    Report Number
    1218058-2024-00042
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Report Date
    April 15, 2024
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 SECTIONS D1 UPDATED, D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED. EVALUATION: THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    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 DURING FUNCTIONAL TESTING, THE ELECTRODE PADS WERE NOT WORKING PROPERLY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. 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
    576687 8900-0224-01 ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 1722E 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown