BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CUFF PRESSURE MONITORING

    MDR report key: 19594758 · Received June 24, 2024

    Report

    Report Number
    3012307300-2024-05352
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 18, 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

    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.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, THIS PRODUCT WAS FOUND TO BE A PFG. THE 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. MFR# 3012307300-2024-05352 WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUFF OF DEVICE CANNOT BE PRESSURIZED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194273 PORTEX CUFF PRESSURE MONITORING PRESSURE MONITORING (AIR/GAS) KIT PXE SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown