BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALOON CATHETER

    MDR report key: 173796 · Received June 19, 1998

    Report

    Report Number
    2248146-1998-00693
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Date of Event
    June 9, 1998
    Report Date
    June 10, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00731) BLOOD BACKED INTO THE SYSTEM 97E PUMP. THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 6/10/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/10/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALOON CATHETER INTRA-AORTIC BALOON CATHETER DSP DATASCOPE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN