BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 160549 · Received March 30, 1998

    Report

    Report Number
    2248146-1998-00338
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Report Date
    March 19, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00346) AFTER IABP FOR 24 HOURS, THE IAB LEAKED. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 3/19/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 3/19/98.

    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