BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3031033 · Received March 28, 2013

    Report

    Report Number
    2249723-2013-00018
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP TESTED THE IABP TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THEY WERE UNABLE TO OBTAIN AN ECG SIGNAL ON THE IABP. THE THIRD PARTY ECG MONITOR SHOWED A SLIGHT ECG WAVEFORM. THE PT WAS SWITCHED TO ANOTHER IABP WITH THE SAME RESULTS. THE HOSPITAL ATTRIBUTES THIS TO THE PT'S CRITICAL CONDITION. THE PT EXPIRED; HOWEVER, THE CUSTOMER DOES NOT ATTRIBUTE THE PT'S DEATH TO THE IABP. THE HOSPITAL REQUESTED THAT THE IABP BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128695 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI