BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188939 · Received September 23, 1998

    Report

    Report Number
    2248146-1998-01090
    Event Type
    Malfunction
    Date Received
    September 23, 1998
    Date of Event
    September 16, 1998
    Report Date
    September 18, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00162) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 10/13/98: POOR AUGMENTATION WAS NOTED DURING IABP. BLOOD WAS THEN NOTED IN THE TUBING. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/18/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/18/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 5/21/00

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR