BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR 40 CC IAB

    MDR report key: 169754 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00554
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 13, 1998
    Report Date
    May 14, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED OR RELEASED TO DATASCOPE FOR EVALUATION. (THIS FOLLOW-UP WAS MAILED TO THE FDA ON 11/16/98).

    Description of Event or Problem · 1

    EVENT: (CC# 98-00587) AFTER IABP FOR 192 HOURS, BLOOD WAS NOTED IN THE IAB. ON 5/26/98, THE FOLLOWING INFORMATION WAS REPORTED: THE IAB WAS INSERTED INTO THE PATIENT 5/6/98 AND REMOVED ON 5/13/98. THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 5/14/98, 5/26/98. [PATIENT'S CURRENT STATUS]: STABLE - RPT'D 5/14/98.

    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. 0784-00-0126 11/14/99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR