BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 114408 · Received August 18, 1997

    Report

    Report Number
    2248146-1997-00880
    Event Type
    Malfunction
    Date Received
    August 18, 1997
    Date of Event
    June 23, 1997
    Report Date
    July 31, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVAL INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 1/28/98).

    Description of Event or Problem · 1

    BLOOD WAS NOTED BACKING UP INTO THE TUBING AND THE IAB WAS REMOVED. (DATASCOPE REC'D THIS REPORT ON 7/31/97 VIA THE VOLUNTARY MEDWATCH FORM FROM THE FDA; TRIAGE UNIT SEQUENCE NUMBER: 66681; MDR ACCESS NUMBER: 1011663). INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVAL. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 7/31/97. [PT'S CURRENT STATUS]: UNK-RPT'D 7/31/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 05/16/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN