BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 19081692 · Received April 10, 2024

    Report

    Report Number
    2249723-2024-01488
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    April 1, 2024
    Report Date
    January 28, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) COMMUNICATED WITH THE CUSTOMER REGARDING THE UNIT OVER THE PHONE. IT WAS REPORTED THE UNIT'S POWER CORD WAS NOT PLUGGED IN AND THE RETAINING CLIP (D343-00-0073) WAS BROKEN. THE CUSTOMER ORDERED A NEW CLIP, AND THE UNIT WILL BE PUT BACK IN SERVICE ONCE THE CLIP IS REPLACED. H3 OTHER TEXT: DEVICE NOT AVAILABLE FOR EVALUATION.

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT TURNS ON, LOOSES POWER AND IS NOT CHARGING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230799 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