BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

    MDR report key: 3905513 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00772
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    November 15, 2013
    Report Date
    November 18, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 COMPANY REPRESENTATIVE OBSERVED THAT THE IABP DID NOT FUNCTION IN BATTERY MODE WHEN A BATTERY WAS INSERTED IN SLOT #2. THE COMPANY REPRESENTATIVE REPLACED THE POWER MANAGEMENT PCB (PART NUMBER 0670-00-0767). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RELEASED TO THE CUSTOMER. THE POWER MANAGEMENT PCB WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4) AND IS UNDER EVALUATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE IABP WOULD NOT RUN ON BATTERY. THE CUSTOMER REPORTED THAT AFTER REMOVING THE UNIT FROM THE TROLLEY OR UNPLUGGING THE UNIT FROM THE AC POWER SOURCE, THE IABP WOULD SHUTDOWN IMMEDIATELY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315042 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1