BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG; STANDARD CART W/ ISOLATION TRANSFORMER

    MDR report key: 6978584 · Received October 25, 2017

    Report

    Report Number
    0002936485-2017-00999
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 27, 2017
    Report Date
    April 9, 2018
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    GTIN: (B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN. ALLEGED FAILURE: SMOKE CAME FROM POWER CORD. PROBABLE ROOT CAUSE: ISOLATION TRANSFORMER MALFUNCTIONS, POWER STRIP MALFUNCTIONS, CIRCUIT OVERLOAD, CURRENT INRUSH, USE ERROR. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMOKE APPEARED AT THE POWER CORD OF THE MEDICAL CART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMOKE APPEARED AT THE POWER CORD OF THE MEDICAL CART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755143 PKG; STANDARD CART W/ ISOLATION TRANSFORMER CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE 080926AM027

    Patients

    Seq Age Sex Outcome Treatment
    1