BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 8110664 · Received November 28, 2018

    Report

    Report Number
    2249723-2018-02070
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Report Date
    January 11, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE SERVICE TERRITORY MANAGER (STM) THAT EVALUATED THE IABP ALSO VERIFIED THAT IN ADDITION TO IDENTIFYING THE DAMAGE FROM SALINE TO THE EXECUTIVE PROCESSOR BOARD AND THE FRONT END BOARD, THE SYSTEM FAILED TO BOOT UP AND WAS ALARMING "INTERNAL COMMUNICATION FAILURE". AFTER THE CUSTOMER APPROVED THE PURCHASE ORDER, THE STM RETURNED TO THE SITE AND REPLACED THE EXECUTIVE PROCESSOR BOARD AND THE FRONT END BOARD. DURING REASSEMBLING OF THE UNIT, IT WAS NOTED THE GASKET AROUND THE EXTERNAL BLOOD PRESSURE (BP) MONITOR CONNECTION WAS DAMAGED AS WELL. TO RESOLVE THIS ISSUE, THE STM ORDERED AND REPLACED THE UPPER PANEL ASSEMBLY AND THE STICKERS IDENTIFYING THE CONNECTIONS. IN ADDITION, THE STM COMPLETED PREVENTATIVE MAINTENANCE (PM) AND PERFORMED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS, WHICH PASSED PER FACTORY SPECIFICATIONS. THE IABP WAS RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED AN "INTERNAL COMMUNICATION FAILURE", FAILS TO BOOT UP, AND GENERATES A LOUD AUDIBLE ALARM. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE SERVICE TERRITORY MANAGER (STM) EVALUATED THE IABP AND IDENTIFIED THAT THE FRONT END BOARD AND THE EXECUTIVE PROCESSOR HAD VISIBLE DAMAGE FROM AN APPARENT SALINE SPILL. HOWEVER, THE CUSTOMER HAS NOT YET APPROVED THE PURCHASE ORDER FOR THE REPAIRS TO BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED AN "INTERNAL COMMUNICATION FAILURE", FAILS TO BOOT UP, AND GENERATES A LOUD AUDIBLE ALARM. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949118 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1