BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 176701 · Received July 10, 1998

    Report

    Report Number
    2248146-1998-00784
    Event Type
    Malfunction
    Date Received
    July 10, 1998
    Report Date
    June 30, 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# 98-00832) THE CUSTOMER ORDERED A 34CC IAB AND A 40CC IAB WAS SHIPPED TO THE FACILITY. THIS WAS DISCOVERED DURING A CHECK OF THE RECEIVED ITEM. THE PRODUCT WAS NEVER USED ON A PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00833, 98-00834) NO ITEM WAS RETURNED TO DATASCOPE. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 6/30/98. [PATIENT'S CURRENT STATUS]: NONE - REPORTED 6/30/98.

    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. 0684-00-0283 05/21/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN