BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2961176 · Received January 30, 2013

    Report

    Report Number
    2249723-2013-00002
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 25, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED "HIGH DRIVE PRESSURE" AND "ELECTRICAL TEST FAILURE CODE #52" (DRIVE TRANSDUCER OFFSET FAILURE) ALARMS. THE CUSTOMER REBOOTED THE IABP AND THE "ELECTRICAL TEST FAILURE CODE #52" WAS DISPLAYED AGAIN. THEY RECYCLED POWER AGAIN, BUT THE IABP GENERATED "LOW VACUUM" AND "SYSTEM FAILURE" ALARMS. AFTER ANOTHER RECYCLE, ETF 52 WAS DISPLAYED AGAIN. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40121 CS300 INTRA-AORTIC BALLOON DSP DATASCOPE CORP CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI