BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188251 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01032
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Report Date
    September 1, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01107) THE IAB LEAKED DURING INSERTION AND THE IAB WAS REMOVED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01106). ON 3/15/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/1/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/1/98.

    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. 0684-00-0306 05/08/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN