BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 176795 · Received July 10, 1998

    Report

    Report Number
    2248146-1998-00738
    Event Type
    Malfunction
    Date Received
    July 10, 1998
    Report Date
    June 24, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00782) AFTER IABP FOR TWO DAYS, THE IAB LEAKED AND THE IAB WAS REMOVED. ANOTHER IAB WAS INSERTED BECAUSE THE PATIENT WAS BALLOON DEPENDENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00781) ON 1/27/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 6/24/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/24/98.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN