BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, CONNECTED OR HUB BASE SYSTEM

    MDR report key: 8471347 · Received April 1, 2019

    Report

    Report Number
    0002936485-2019-00127
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 5, 2019
    Report Date
    July 11, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OUG
    PMA / PMN Number
    K181258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: THE VIDEO ON THE MONITORS FROZE ON TWO OCCASIONS DURING A PROCEDURE. VIDEO OUTPUT FROZE ON BOTH OF THE CONNECTED MONITORS AT THE SAME TIME. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSES COULD BE 1688, HUB SOFTWARE, HUB SDK, 4K DISPLAY, OR CABLES. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FROZEN IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD FROZEN IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263345 PKG, CONNECTED OR HUB BASE SYSTEM MEDICAL DEVICE DATA SYSTEM OUG STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1