BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 20278286 · Received September 23, 2024

    Report

    Report Number
    2249723-2024-0003869
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 23, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107790
    PMA / PMN Number
    K031636
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION BLOCK E1EVENT SITE NAME IS HANGZHOU FIRST PEOPLE'S HOSPITAL. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY WERE ABLE TO CONFIRM THE ISSUE. THE FSE REPLACED THE SHOCK ABSORBER PAD (0348-00-0169-01). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) INSTRUMENT MAKES ABNORMAL WORKING SOUND. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503268 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-45 10607567107790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown