BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 147188 · Received January 28, 1998

    Report

    Report Number
    2248146-1998-00054
    Event Type
    Malfunction
    Date Received
    January 28, 1998
    Date of Event
    January 14, 1998
    Report Date
    January 15, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: THE IAB DID NOT INFLATE FULLY. (MULTIPLE EVENT TO CUSTOMER COMPLAINT 98-00054) ON 2/20/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE DISTAL END OF THE BALLOON WOULD ONLY INFLATE INTERMITTENTLY. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 1/14/1998. THE PT WENT ONTO EXPIRE ON 1/17/1998 AT 10:15 PM. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 1/15/1998 AND 2/20/1998. [PT'S CURRENT STATUS]: EXPIRED ON 1/17/1998.

    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. 0684-00-0306 12/10/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR