BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUIDSMART FLUID MANAGEMENT SYSTEM

    MDR report key: 15328325 · Received August 31, 2022

    Report

    Report Number
    3007495879-2022-00005
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    December 22, 2021
    Report Date
    August 31, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: ON (B)(6) 2021 MATT WOLFE (TECH SERVICE) RECEIVED A CALL FROM (B)(6) (REP) EXPLAINING THAT SN (B)(4) WAS PRESENTING AN OVERPRESSURE SENSOR ERROR ALARM. PER 00824 OPERATION MANUAL REV K. AN OVER PRESSURE ALARM WILL PRESENT ITSELF WHEN THE PRESSURE SET POINT EXCEEDS 10% OR 12MM/HG. NO ONE WAS INJURED AS A RESULT. PROBABLE ROOT CAUSE/ROOT CAUSE: INCORRECT PROCEDURE SELECTION, OR INSUFFICIENT FLUID PRESSURE OR FLOW, COMPROMISING VISIBILITY. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN OVERPRESSURE SENSOR ERROR ALARM. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180039 FLUIDSMART FLUID MANAGEMENT SYSTEM INSUFFLATOR, HYSTEROSCOPIC HIG STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown