BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 173623 · Received June 19, 1998

    Report

    Report Number
    2248146-1998-00705
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Date of Event
    June 16, 1998
    Report Date
    June 17, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00743) AFTER IABP FOR TWO WEEKS, THE IAB LEAKED. ON 1/27/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 6/17/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/17/98.

    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