BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3902595 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00553
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP VERIFIED THE FAULT LOG. THE COMPANY REP REPLACED THE PCB (PART NUMBER 0997-00-1162) FOR THE FIBER OPTIC MODULE (P/N 0992-00-0290). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE FIBER OPTIC MODULE FAILURE COULD NOT BE DUPLICATED DURING EVALUATION OF THE RETURNED PART. THE FIBER OPTIC MODULE WAS PUT INTO A TEST UNIT AND CYCLED MORE THAN (B)(4) TIMES OVER A (B)(4) PERIOD. THE FIBER OPTIC ASSEMBLY WAS DESIGNATED FOR TEST FIXTURE USE AND WAS NOT PUT BACK INTO INVENTORY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT THE IABP GENERATED A "FIBER OPTIC FAILURE" ALARM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282284 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1