BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 23836090 · Received December 18, 2025

    Report

    Report Number
    2249723-2025-0005159
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 28, 2025
    Report Date
    March 30, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107790
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION IN BLOCK E1. E1 INITIAL REPORTER NAME IS (B)(6). E1 EVENT SITE TELEPHONE IS (B)(6). UPDATED FIELDS: B4, B5, B6 , B7, D10, D9, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE , HEALTH EFFECT ¿ IMPACT CODES ), H11 , E1 ( INITIAL REPORTER , EVENT SITE TELEPHONE ). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE EQUIPMENT ALARMED UPON STARTUP, AND THE ELECTRICAL TEST FAILED. THE CIRCUIT BOARD (0670-00-0668) AND SHOCK-ABSORBING ADHESIVE (0348-00-0169-01) WERE REPLACED. AFTER REPLACEMENT, ALL FUNCTIONAL PARAMETERS OF THE EQUIPMENT WERE TESTED AND THE EQUIPMENT WAS DELIVERED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME- (B)(6). EVENT SITE ADDRESS-(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) AUTOMATICALLY FAILED TO INFLATE AND FAILURE CODE #53 WAS DISPLAYED. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) AUTOMATICALLY FAILED TO INFLATE AND FAILURE CODE #53 WAS DISPLAYED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185902 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