BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 11776221 · Received May 5, 2021

    Report

    Report Number
    2249723-2021-00940
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Report Date
    January 11, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS; B4, D10, G3, G6, G7, H2, H6, H10, H11. CORRECTED FIELDS: G1, H4.

    Additional Manufacturer Narrative · 0

    UPDATED: B4, B6, B7, E2, E3, G3, G4, G7, H2, H10, H11. CORRECTED: D1. ADDITIONAL CONTACT INFORMATION FOR THE INITIAL REPORTER WAS PROVIDED AND IS AS FOLLOWS: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE IABP UNIT AND RESOLVED THE ISSUE BY REPLACING THE VACUUM HOSE IN ITS' ENTIRETY, AS WELL AS THE MOTOR CONTROL BOARD. THE FSE DETERMINED THAT THE LEAK WAS AS A RESULT OF A NUMBER OF COMPONENTS AND THE FOLLOWING PARTS WERE REPLACED: PNEU CMPNT NIP .25 FLOW BULKHD, HOSE,COMPRESSOR VP2 TO MP1, HOSE COMPRESSOR BP1 TO VP1, HOSE ASSY #5 VACUUM V1 THRU V6, TUBING ASSY,VACUUM,V7,V8, HYDR CMPNT PUMP ASSY DC KNF, AND HOSE ASSY #5 VACUUM V1 THRU V6. THE FSE THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673276 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose UNKNOWN.