BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 135199 · Received November 25, 1997

    Report

    Report Number
    2248146-1997-01274
    Event Type
    Malfunction
    Date Received
    November 25, 1997
    Date of Event
    November 11, 1997
    Report Date
    November 11, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738 DEVICE LABEL CODE FOR F10. POSITION 2: 1701 DEVICE LABEL CODE FOR F10. POSITION 3: -

    Description of Event or Problem · 1

    EVENT: CC# 97-01363) POOR AUGMENTATION WAS NOTED DURING IABP. ON 12/18/1997, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE BALLOON WOULD NOT AUGMENT AND THE IAB CATHETER ALARM SOUNDED. WHEN THE ALARM OCCURRED, THE IAB WAS MANUALLY INFLATED WITHOUT DIFFICULTY. THE BALLOON APPEARED TO BE OUT OF THE SHEATH AS PER THE X-RAY. THE IAB PUMPED INTERMITTENTLY WITH THE CATHETER ALARM SOUNDING. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 11/11/1997; NONE - REPORTED 12/18/1997. [PT'S CURRENT STATUS]: UNKNOWN - RPT'D 11/11/1997.

    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 CORPORATION 0684-00-0269 8/8/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN