BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 169693 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00574
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 13, 1998
    Report Date
    May 13, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00608) THE IAB LEAKED BACK INTO THE SYSTEM 90 PUMP. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 5/13/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 5/13/98.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN