BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 16274607 · Received January 31, 2023

    Report

    Report Number
    2249723-2023-00849
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    May 28, 2021
    Report Date
    March 29, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. THE FSE REPLACED THE DISPLAY COVER (0380-00-04221), CLUTCH (0105-00-00712), AND RETAINER (0380-00-02102 ). THE FSE THEN PERFORMED FUNCTIONAL AND SAFETY TESTS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS DISPLAY COVER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789513 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.