BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED OR MOUNT

    MDR report key: 14350071 · Received May 10, 2022

    Report

    Report Number
    0002936485-2022-00223
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 13, 2022
    Report Date
    June 15, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    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: MONITOR ARM ISSUES PROBABLE ROOT CAUSE: ¿ MONITOR ARM DESIGN 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 THE ARM OF CART WAS DRIFTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARM OF CART WAS DRIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153520 CONNECTED OR MOUNT CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown