BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3874767 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00521
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    September 30, 2013
    Report Date
    September 30, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) REPRESENTATIVE CONFIRMED THE COMPLAINT FOR "ELECTRICAL TEST FAILURE CODE #6." THE (B)(4) REPRESENTATIVE VERIFIED THAT THE TOUCH SCREEN WAS OUT OF CALIBRATION AND PERFORMED TOUCH SCREEN CALIBRATION. THE REPRESENTATIVE ADJUSTED THE VACUUM REGULATOR AND FOUND THAT THE IABP UNIT WAS MISSING PRESSURE FITTING CLAMP ON RESERVOIR OUTLET. THE CLAMP (PART NUMBER 0105-00-0163) AND THE SCREW PAN HEAD (PART NUMBER 0212-12-0403) WERE REPLACED. THE FUNCTIONAL TESTS WERE PERFORMED AND SAFETY INSPECTED. THE IABP MET THE FACTORY SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN IN-SERVICE TRAINING SESSION, THE IABP GENERATED "ELECTRICAL TEST FAILURE CODE #6" (UNABLE TO CONFIGURE TOUCH SCREEN CONTROLLER DEVICE ELECTRICAL TEST FAILURE) ALARMS SEVERAL TIMES. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250643 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1