BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE

    MDR report key: 207796 · Received January 26, 1999

    Report

    Report Number
    MW1015508
    Event Type
    Malfunction
    Date Received
    January 26, 1999
    Date of Event
    October 16, 1998
    Report Date
    December 18, 1998
    Manufacturer
    DATASCOPE CORP. CARDIAC ASSIST
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE MFR ON 03/05/1999: THE PRODUCT WAS NEVER RETURNED TO CO FOR EVALUATION. THE REPORTED LEAK COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE DATASCOPE IABP CATHETER DSP DATASCOPE CORP. CARDIAC ASSIST 40 CC DL 9.5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR