BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 10.5 FR. 50 CC. IAB

    MDR report key: 189904 · Received September 29, 1998

    Report

    Report Number
    2248146-1998-01112
    Event Type
    Malfunction
    Date Received
    September 29, 1998
    Date of Event
    September 24, 1998
    Report Date
    September 24, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC#98-01192) THE IAB LEAKED DURING INSERTION. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01193, 98-01194) THE FOLLOWING WAS REPORTED TO DATASCOPE ON 10/13/98: THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 9/24/98 AND 10/13/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/24/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 10.5 FR. 50 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0194 08/22/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN