BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20985580 · Received December 20, 2024

    Report

    Report Number
    2249723-2024-0005137
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    May 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9 RETURN TO MANUFACTURE DATE, G1 CONTACT PERSON ¿ MFG SITE, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED FIBER OPTIC ASSEMBLY WHICH RESOLVED THE ERROR. BIOMED IS REPLACING THE SAFETY DISK WHEN PART IS RECEIVED. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED WITH A REPORTED UNIT FAILURE OF OPTICAL SENSING MODULE FAILURE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED FIBER OPTIC MODULE INTO THE CS300 TEST FIXTURE AND TESTED THE FIBER OPTIC MODULE TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL. THE FAT PERFORMED THE FIBER OPTIC TEST IN DIAGNOSTICS. THE FIBER OPTIC MODULE PASSED TESTING. THE FAT COULD NOT REPLICATE THE COMPLAINT EXPERIENCED BY THE CUSTOMER. RETAINING THE FIBER OPTIC MODULE IN THE FAT.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1: EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS "OPTICAL SENSING MODULE FAILURE" MESSAGE DISPLAYED DURING PM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150756 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown