BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED OR CART, 120 V

    MDR report key: 14496617 · Received May 25, 2022

    Report

    Report Number
    0002936485-2022-00264
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 28, 2022
    Report Date
    July 7, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    UDI-DI
    00858701006360
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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

    THE DEVICE MANUFACTURER DATE IS NOT KNOWN. 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: TILTS FORWARD EXCESSIVELY. PROBABLE ROOT CAUSE: MONITOR ARM DESIGN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CART ARM WAS DRIFTING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CART ARM WAS DRIFTING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252473 CONNECTED OR CART, 120 V CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE 240099155 00858701006360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown