BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 10135363 · Received June 9, 2020

    Report

    Report Number
    2249723-2020-00889
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 2, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE AC ADAPTER ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DID NOT CHARGE ON LEFT BATTERY SIDE. THERE WAS NO HARM OR INJURY TO PATIENT 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) WAS DISPATCHED TO EVALUATE THE IABP AND AFTER WORKING TOGETHER WITH BIOMEDICAL ENGINEER; THE ISSUE WAS DETERMINED TO BE THE TRANSPORT PWS. WHEN PLUGGED INTO SLOT 1 IN TRANSPORT, DISPLAY WOULD SHOW NOT RECOGNIZED. WHEN PLUGGED INTO SLOT 2 THE TRANSPORT PWS WOULD BE RECOGNIZED. THE STM TROUBLESHOT THE UNIT AND FOUND THAT THE POWER MANAGEMENT BOARD WAS CORRODED FROM A BLOOD BACK ISSUE (MAR 2020) WITH THIS UNIT. THE STM REPLACED THE POWER MANAGEMENT BOARD UNIT NOW WORKS WITH TRANSPORT PWS IN BOTH SLOTS. ALL FUNCTIONAL AND SAFETY TESTS WERE PASSED TO MEET FACTORY SPECIFICATIONS, AND THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. FULL EVENT SITE NAME: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE AC ADAPTER ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DID NOT CHARGE ON LEFT BATTERY SIDE. THERE WAS NO HARM OR INJURY TO PATIENT AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597371 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1