BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188398 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01058
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    September 8, 1998
    Report Date
    September 9, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01133) THE BALLOON LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/2/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS OBSERVED IN THE TUBING BY THE NURSING STAFF. THE BLOOD WAS NOTICED BEFORE ANY ALARMS SOUNDED FROM THE PUMP. THE IAB WAS REMOVED AND ANOTHER WAS NOT INSERTED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT REMAINED STABLE AFTER THE EVENT. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/9/98; NONE - RPT'D 10/2/98. [PATIENT'S CURRENT STATUS]: PT. STABLE-RPT'D 10/2/98.

    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. 0684-00-0269 12/14/99

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR