BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAL DL 9.5 FR. 34 CC. IAB

    MDR report key: 168297 · Received May 14, 1998

    Report

    Report Number
    2248146-1998-00541
    Event Type
    Malfunction
    Date Received
    May 14, 1998
    Date of Event
    April 28, 1998
    Report Date
    May 12, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 07/08/1998). EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. RPBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    THE "GAS LOSS" ALARM SOUNDED FROM THE SYSTEM 90T PUMP AND THE PUMP STOPPED. BLOOD WAS NOTED IN THE EXTENSION TUBING WHEN THE INTRA AORTIC BALLOON WAS REMOVED. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 5/12/1998. PT'S CURRENT STATUS: UNK - REPORTED 5/12/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAL DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP 0784-00-0115 12/5/98

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR