BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 153782 · Received February 26, 1998

    Report

    Report Number
    2248146-1998-00230
    Event Type
    Malfunction
    Date Received
    February 26, 1998
    Report Date
    February 25, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 11/16/98).

    Description of Event or Problem · 1

    EVENT: (CC# 98-00242) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/27/98, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 2/25/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 2/25/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN