BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE MULTIPHRAM ACC ECG CABLE 3-LEAD SHIELDED

    MDR report key: 21333499 · Received February 7, 2025

    Report

    Report Number
    3008818980-2025-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 7, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DSA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. H4. DEVICE MFG DATE: THE REPORTED LOT# 848214583 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 21-0460-51; THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ECG CABLE WAS DEFECTIVE. THE MONITOR WAS NOT READING ECG OR WOULD READ INACCURATELY. THE EVENT OCCURRED AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107299 REUSABLE MULTIPHRAM ACC ECG CABLE 3-LEAD SHIELDED CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA SMITHS MEDICAL ASD, INC. 848214583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown