BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 13224337 · Received January 11, 2022

    Report

    Report Number
    2249723-2022-00052
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 16, 2021
    Report Date
    June 29, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE (10/3233): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT. THE FSE CHECKED IF THE POWER ON THE SCREEN HAD WHITE STRIPES. THE FSE CHANGED THE BOARD PCB, COLOR VIDEO RECEIVER WITH A NEW BOARD. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE (10/3233): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT. THE FSE CHECKED IF THE POWER ON THE SCREEN HAD WHITE STRIPES. THE FSE REPLACED THE COLOR VIDEO RECEIVER BOARD AND NOTED A PIECE OF CABLE WAS STILL PENDING DELIVERY IN ORDER TO COMPLETE REPAIRS. SUBSEQUENTLY, THE FSE RETURNED TO THE CUSTOMER'S SITE AT A LATER DATE AND REPLACED THE VIDEO RECEIVER TO LCD CABLE. ALL SAFETY, FUNCTIONALITY AND CALIBRATION TESTS WERE PERFORMED AND PASSED AND THE IABP UNIT WAS THEN CLEARED FOR USE AND RETURNED TO THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREEN THAT WAS DISPLAYING WHITE LINES AND FLICKERED. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688155 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-55 N/A 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown