BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 49280 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00085
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Report Date
    August 26, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE "RAPID GAS LOSS" ALARM SOUNDED FROM THE PUMP. ALL CONNECTIONS WERE CHECKED BUT THE BALLOON WOULD NOT PUMP AND THE IAB WAS REMOVED. ANOTHER WAS NOT INSERTED. THE IAB WAS NOT RETURNED TO CO. FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN