BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB, ALT B

    MDR report key: 188340 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01053
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 25, 1998
    Report Date
    September 8, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIALLY, THE DR COULD NOT REMOVE THE IAB FROM THE TRAY. ANOTHER IAB WAS USED. AFTER THE PT'S OPERATION, THE DR PULLED THE IAB BY FORCE AND REMOVED THE IAB FROM THE TRAY. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 09/08/1998. PT'S CURRENT STATUS; UNK - RPT'D 09/08/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB, ALT B INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0784-00-0141 06/08/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN