BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 7313851 · Received March 5, 2018

    Report

    Report Number
    2249723-2018-00344
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Report Date
    March 2, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER THE 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 NOTED THAT IT WAS NOT CHARGING THE BATTERIES AND THAT THE POWER SUPPLY WAS DEFECTIVE. THE STM UPGRADED THE CARDIOSAVE CART POWER SUPPLY. HE THEN COMPLETED FULL PREVENTIVE MAINTENANCE, SAFETY, CALIBRATION AND FUNCTIONAL CHECKS. THE IABP PASSED ALL TESTING AND WAS DEEMED SAFE TO OPERATE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP HAD A POWER SUPPLY ISSUE. THE CIRCUMSTANCES UNDER WHICH THIS EVENT OCCURRED ARE UNKNOWN. HOWEVER, NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. THIS CARDIOSAVE IS A TRAINING IABP USED BY GETINGE TECH SUPPORT AND IS NOT FOR CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155482 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1