BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSPAC II TRANSDUCER

    MDR report key: 13722 · Received June 2, 1994

    Report

    Report Number
    MW1002322
    Event Type
    Injury
    Date Received
    June 2, 1994
    Date of Event
    April 29, 1994
    Report Date
    May 17, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WAVEFORM FOR PULMONARY ARTERY SHOWED CONTINUOUS INTERFERENCE. RN PERFORMED TROUBLESHOOTING BY CHANGING OUT TRANSDUCER THEN REUSABLE TRANSDUCER THEN REUSABLE TRANSDUCER CABLE. SHE NOTED THAT THE PRESSURE CABLE WAS CORRODED AND THAT THE TRANSDUCER CONNECTOR WAS BLACKENED. BOTH THE RESUABLE CABLE AND THE TRANSDUCER WERE SAVED FOR THE BIOMEDICAL ENGINEERING DEPARTMENT TO EXAMINE. NO INJURY OR INCONSEQUENTIAL INJURIES OR EFFECT WERE REPORTED. EXAMINATION OF THE TRANSDUCER AND TRANSDUCER CABLE REVEALED CROSS CORROSION OF BOTH CONNECTORS, WHICH WAS PROBABLY DUE TO FLUID CONTAMINATION. BOTH WERE PERMANENTLY REMOVED FROM SERVICE. (ALSO SEE 1002321.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC II TRANSDUCER IABP TRANSDUCER DRS ABBOTT LABORATORIES TRANSPAC II 42548-01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention