BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 15735065 · Received November 4, 2022

    Report

    Report Number
    2249723-2022-02844
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 27, 2022
    Report Date
    May 23, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP FOR THE REPORTED MALFUNCTION. THE FSE DISASSEMBLED THE UNIT AND REMOVED ALL DAMAGED PARTS. THE FSE REPLACED THE TOP COVER (0380-00-0497), FIBER-OPTIC ASSEMBLY (0997-00-1161), AND THE FIBER-OPTIC CONNECTOR PANEL (0997-00-0527). THE FSE REASSEMBLED THE DEVICE AND PERFORMED FUNCTION TESTS. THE FSE RESET THE DEVICE AND OBSERVED AN ERROR ALARM SHOWING AP OPTICAL MODULE FAILURE. THE FSE REPLACED THE IAB DATASETTE (0670-00-1187) AND THE DSS DATASETTE (0670-00-1186). THE UNIT WAS TESTED AND WAS FOUND TO BE WORKING OKAY. THE ELECTRICAL SAFETY TEST WAS PASSED BY HOSPITAL BIOMED. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SECTION OF UNIT CRUSHED, THE CHASSIS AND ELECTRONIC BOARDS WERE DAMAGED. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE PATIENT USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SECTION OF UNIT CRUSHED, CHASSIS AND ELECTRONIC BOARDS DAMAGED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213002 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN.