BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 18607155 · Received January 30, 2024

    Report

    Report Number
    2249723-2024-00357
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 18, 2024
    Report Date
    October 16, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND NOTICED INTERMITTENT LINES THROUGH DISPLAY. THE FSE REPLACED VIDEO RECEIVER TO LCD CABLE AND THE DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE UNIT WAS RETURNED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1429 REV. B, SERIAL NUMBER (B)(6), WITH A REPORTED UNIT FAILURE OF A DISPLAY ISSUE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED PART NUMBER 0012-00-1429 INTO CS100 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS100 SERVICE MANUAL. NO ISSUES FOUND IN THE DISPLAY. FAT COULD NOT CONFIRM THE REPORTED FAILURE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DISPLAY ISSUE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550656 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown