BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS100

    MDR report key: 4182089 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00002
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    January 5, 2014
    Report Date
    January 6, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE TECHNICAL SERVICE REPRESENTATIVE VERIFIED THE PROBLEM. THE UNIT WAS PLUGGED IN THE INDICATED A FULL CHARGER PRIOR TO PERFORMING A BATTERY RUNTIME TEST. THE EXPIRED BATTERIES WERE REPLACED AND VERIFIED THAT THE BATTERY FUNCTION AND CHARGING CIRCUIT IS OPERATIONAL. PERFORMED COMPLETE PERFORMANCE AND FUNCTION TEST AND THE UNIT WAS FOUND TO BE FUNCTIONING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP SHUT DOWN AFTER BEING UNPLUGGED FROM THE AC OUTLET FOR TRANSPORT. THE IABP WAS PLUGGED BACK INTO THE AC OUTLET AND THERAPY WAS CONTINUED UNTIL THE PT WAS SWITCHED TO ANOTHER IABP. THERAPY WAS CONTINUED ON THE REPLACED IABP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185104 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other