BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 20471889 · Received October 17, 2024

    Report

    Report Number
    2249723-2024-0004265
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 16, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE MACHINE TELEPHONICALLY AND FOUND THE ISSUE WITH THE CABLE DISPLAY TO VIDEO RECEIVER. THE FSE REPLACED THE DISPLAY TO VIDEO RECEIVER CABLE (0012-00-1429) WITH NEW ONE. ALL FUNCTIONAL AND SAFETY TEST WERE PERFORMED. UNIT WAS HANDED OVER TO CUSTOMER FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS FLICKERING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367298 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown