BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 167217 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00507
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    April 27, 1998
    Report Date
    May 1, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: VISUAL EXAMINATION REVEALED THE MEMBRANE AT THE PROXIMAL TAPER TO BE STRETCHED. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. IT WAS NOT POSSIBLE TO PUMP THE IAB ON THE LAB SYS 97 IABP IN THE LAB DUE TO THE CONDITION OF THE RETURNED MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNED IAB. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION OF THE RETURNED PRODUCT. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/8/98).

    Description of Event or Problem · 1

    THE "GAS LEAK" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED BACK INTO THE TUBING AND PUMP. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00538). [EVENT COMPLICATIONS]: UNK-REPORTED 5/1/98; NONE-REPORTED 6/10/98. [PT'S CURRENT STATUS]: EXPIRED-RPT'D 6/10/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0307 11/03/99

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR