BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20911280 · Received December 12, 2024

    Report

    Report Number
    2249723-2024-0005019
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 19, 2024
    Report Date
    April 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G4 (PMA/510(K)#, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED HANDLE CONSOLE RELEASE (D367-00-0091), BRACKET LOCKING CART (D406-00-0860) AND SHOULDER SCREW (D212-00-0096) FOR LATCH. RAN ALL THE TESTS IN ACCORDANCE TO THE MANUFACTURER'S SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND OBSERVED THAT THE PEM FASTENER ON THE BRACKET WAS DAMAGED, WHICH IS THE PROBABLE CAUSE OF THE MALFUNCTIONING OF THE HANDLE RELEASE. RETAINING THE LOCKING BRACKET IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(4) REV. AS. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HANDLE, CONSOLE RELEASE MALFUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154097 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown