BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3871979 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00511
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE DISPLAY BECAME RED FROM MOVING OR TAPPING THE DISPLAY. THE COMPANY REP REPLACED THE LCD (PART NUMBER 0160-00-0085) AND THE UPPER DSP TO ICD CABLE (0012-00-1558). THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONAL NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE DISPLAY TURNED RED. THE CUSTOMER TAPPED THE DISPLAY AND THE DISPLAY RETURNED TO NORMAL. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235912 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1