BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG; STANDARD CART W/ ISOLATION TRANSFORMER

    MDR report key: 10213549 · Received June 30, 2020

    Report

    Report Number
    0002936485-2020-00250
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    December 1, 2019
    Report Date
    September 3, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: SPARKING PROBABLE ROOT CAUSE: TOO MUCH HEAT TRANSFORMER DESIGN CART DESIGN MANUFACTURING NONCONFORMITY (TEKNA) USE ERROR THE DEVICE MANUFACTURE DATE IS NOT KNOWN. 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SPARKING ON PLUGGING IN THE DEVICE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SPARKING ON PLUGGING IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679582 PKG; STANDARD CART W/ ISOLATION TRANSFORMER CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1