BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 TRAUMA FAST FLOW SYSTEM

    MDR report key: 13040233 · Received December 18, 2021

    Report

    Report Number
    3012307300-2021-12713
    Event Type
    Malfunction
    Date Received
    December 18, 2021
    Report Date
    March 11, 2022
    Manufacturer
    OAKDALE
    Product Code
    BSB
    UDI-DI
    50695085829506
    PMA / PMN Number
    BK020043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. THIS RETURN TUBE ISSUE IS BEING ADDRESSED THROUGH CAPA-000399. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVIVCE DID NOT HEAT OR PUMP FLUID. ISSUE IDENTIFIED DURING TESTING WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932666 LEVEL 1 TRAUMA FAST FLOW SYSTEM WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB OAKDALE H-1200 50695085829506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown