BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED OR CART, 120 V

    MDR report key: 11803359 · Received May 10, 2021

    Report

    Report Number
    3012345110-2021-00001
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 29, 2021
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    UDI-DI
    00858701006360
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: IMAGE LOSS. PROBABLE ROOT CAUSE: MONITOR ARM DESIGN USE ERROR . THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

    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 THERE WAS LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700024 CONNECTED OR CART, 120 V CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE 240099155 00858701006360

    Patients

    Seq Age Sex Outcome Treatment
    1