BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 15910384 · Received December 2, 2022

    Report

    Report Number
    2249723-2022-03087
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 21, 2022
    Report Date
    March 30, 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
    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

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE STATED THAT THE UNIT WAS NOT TURNING ON WITH ERROR # 5. IN ADDITION, THE LCD WAS NOT WORKING. THE FSE INSPECTED THE LCD AND FOUND THAT THE DISPLAY CABLE WAS NOT CONNECTED PROPERLY TO THE VIDEO RECEIVER PCB. THE FSE REINSTALLED AND CHECKED ALL CONNECTIONS ON THE MONITOR. THE FSE REPLACED THE DISPLAY TO VIDEO RECEIVER BOARD CABLE (0012-00-1429), COLOR VIDEO RECEIVER PCB (0670-00-0736), AND THE MAIN BOARD PCB (0670-00-0788). THE UNIT WAS TESTED AND FOUND TO BE WORKING PROPERLY. THE ELECTRICAL SAFETY TESTED PASSED. 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) PANEL SHOWING DISTORTION. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) PANEL SHOWING DISTORTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960710 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 N/A.| UNKNOWN.