BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CUFF PRESSURE MONITORING

    MDR report key: 19476762 · Received June 6, 2024

    Report

    Report Number
    3012307300-2024-04600
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    PXE
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, THE REPORTED ITEM# WAS FOUND TO BE A PFG. THIS DEVICE DOES NOT HAVE A 510K OR SALES IN THE UNITED STATES, NOR ARE THERE ANY SUBSTANTIALLY SIMILAR DEVICES SOLD IN THE US. THEREFORE, NO REGULATORY REPORTING IS REQUIRED TO THE FDA FOR THIS ISSUE. THE EMDR WAS REPORTED IN ERROR AND WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE CANNOT BE MEASURED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980300 PORTEX CUFF PRESSURE MONITORING PRESSURE MONITORING (AIR/GAS) KIT PXE SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown