BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5FR. 40CC. IAB

    MDR report key: 46174 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00064
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Report Date
    August 27, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. THE PENETRATION HAS THE CHARACTERISTICS TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECT TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. DEVICE LABEL CODE: 1738.

    Description of Event or Problem · 1

    (IAB S/N J1419024). THE "GAS LOSS" ALARM SOUNDED FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5FR. 40CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0784000108-11 4/12/98

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN