BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    MDR report key: 13500342 · Received February 9, 2022

    Report

    Report Number
    3012307300-2022-03053
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    June 4, 2021
    Report Date
    February 9, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS MEDICAL. MEASURED THE DIMENSIONS OF THE GASKETS AS RETURNED AND ALL APPEARED TO MEET SPECIFICATION. A CABLE CONNECTOR WAS CONNECTED TO EACH UNIT AND EACH UNIT SHOWED SLIGHT COMPRESSION OF THE GASKET WHEN CONNECTED AS REQUIRED. FUNCTIONALITY WAS TESTED PER INTERNAL TEST PROCEDURE OP.000272. THE UNIT WITH SN# LS030 FAILED INITIAL TESTING AND WAS RETESTED; THE UNIT FAILED THE SECOND TEST SEQUENCE. THE FAILED UNIT APPEARS TO BE ISOLATED IN OCCURRENCE, NO PHYSICAL DAMAGE NOTED FOR THE OUTSIDE OF EACH UNIT, WHEN OPENED THERE WERE MARGINAL SOLDER CONNECTIONS AS RECEIVED. DHR: NO CAUSES OR POTENTIAL CAUSES TO THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE DHR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTION POINT CABLE PRESSURE PICKUP WAS NOT TIGHT -> HUMIDITY ENTERS -> ZERO ADJUSTMENT NO LONGER POSSIBLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85832 MEDEX LOGICAL PRESSURE MONITORING SYSTEM TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown