BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR 40 CC IAB

    MDR report key: 165224 · Received April 27, 1998

    Report

    Report Number
    2248146-1998-00434
    Event Type
    Malfunction
    Date Received
    April 27, 1998
    Report Date
    April 13, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 11/16/98).

    Description of Event or Problem · 1

    EVENT: (CC# 98-00457) THE BALLOON HAD A PIN HOLE LEAK IN THE CENTER OF THE BALLOON AND BLOOD DROPLETS WERE NOTED IN THE BALLOON LINE TO THE PUMP. ON 4/16/98, DATASCOPE WAS NOTIFIED THAT A SECOND IAB WAS INSERTED INTO THE PATIENT WITHIN A 3 HOUR TIME FRAME. THIS IAB DID NOT MALFUNCTION. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 4/13/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 4/13/98.

    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. 0684-00-0306 11/24/99

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR