BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2862160 · Received November 29, 2012

    Report

    Report Number
    2249723-2012-00367
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 6, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIOMED WAS UNABLE TO DETERMINE IF THE BATTERY WAS FULLY CHARGED PRIOR TO THE EVENT. HE ADVISED THAT THE BATTERY WOULD NOT RUN FOR 1.5 HOURS DURING A RUNTIME TEST. A COMPANY SERVICE REPRESENTATIVE SUBSEQUENTLY EVALUATED THE IABP, AND OBSERVED THAT THE BATTERIES WERE NOT PROPERLY SECURED TO THE CART. THERE WAS A 2 INCH GAP BETWEEN CONSOLE AND THE CART. THE COMPANY REPRESENTATIVE SEATED THE CONSOLE PROPERLY AND REPLACED THE BATTERIES AT THE CUSTOMER'S REQUEST. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT DURING TRANSPORT THE IABP ALARMED "LOW BATTERY" AND IMMEDIATELY SHUTDOWN. 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
    1 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK