BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20325001 · Received September 27, 2024

    Report

    Report Number
    2249723-2024-0003957
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 4, 2024
    Report Date
    March 11, 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(DEVICE AVAILABLE FOR EVAL, RETURN TO MANUFACTURE DATE), G1, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. FSE REPLACED COMPRESSOR FAN (0119-00-0149). COMPLETED THE SCHEDULED PM. FSE NOTED ECG LEADS MISSING/NOT PRESENT, ADVISED THE INHOUSE BIOMED TEAM TO GARNISH NEW ECG CABLES A QUOTE WILL BE PROVIDED UPON REQUEST. RAN ALL THE TESTS IN ACCORDANCE TO THE MANUFACTURER'S SPECIFICATIONS. ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 10 DEC 2024. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0119-00-0149 FAN COMPRESSOR SERIAL NUMBER N/A WITH A REPORTED UNIT FAILURE OF THE FAN MAKING NOISE WHEN TURNED ON. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND OBSERVED A BROKEN BLADE OF THE FAN. POSSIBLY, A PROBABLE CAUSE OF THE FAN BEING NOISY WHEN THE UNIT WAS TURNED ON IS, THE BLADE WAS IN THE PROCESS OF BEING SHEARED OFF WHEN THE UNIT WAS TURNED ON, OR A PIECE OF THE BLADE WAS HANGING AND PRODUCING THE NOISE. HOW THE FAN WAS DAMAGED IS IMPOSSIBLE TOO EXPLAIN. THE FAN IS PROTECTED BY A SIDE PANEL THAT COMPLETELY COVERS THE FAN. RETAINING THE FAN IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5, D5, E1 (INITIAL REPORTER AND EMAIL), E2, E3, E4. UPDATED DATA: B4, G2, G3, G6, H2, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN TURNED ON, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAN IS MAKING NOISE WHEN TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAN IS MAKING NOISE WHEN TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433084 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