BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 98

    MDR report key: 3872085 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00458
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM AFTER RUNNING THE UNIT FOR ONE HOUR. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. INTERNAL REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THEY FAILED TO GET AN ECG SIGNAL. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235277 SYSTEM 98 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYSTEM 98

    Patients

    Seq Age Sex Outcome Treatment
    1