BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    MDR report key: 23049321 · Received September 15, 2025

    Report

    Report Number
    2249723-2025-0003823
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 22, 2025
    Report Date
    February 26, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11,B5, H6 (COMPONENT CODE). CONTACTED CUSTOMER DEPARTMENT SEVERAL TIMES FOR LOCATION OF BALLOON PUMP. SEARCHED THROUGH OUT (B)(6) MEDICAL AND (B)(6) HOSPITAL. UNABLE TO LOCATE UNIT. WILL CLOSE OUT SERVICE REPORT. SERVICE CALL CANCELLED. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, B8, D9 (DEVICE AVAILABLE FOR EVAL), D10, E1 (INITIAL REPORTER, EVENT SITE EMAIL), E3, G3, G4 (PMA/510(K)#), G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, HEALTH EFFECT IMPACT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D1 (BRAND NAME), H6 (MEDICAL DEVICE PROBLEM CODE). 510K OF UPGRADED DEVICE (CS300): K063525. A GETINGE FIELD SERVICE ENGINEER (FSE) CONTACTED CUSTOMER DEPARTMENT SEVERAL TIMES FOR LOCATION OF BALLOON PUMP. SEARCHED THROUGH OUT (B)(6) MEDICAL AND (B)(6) HOSPITAL. UNABLE TO LOCATE UNIT. WILL CLOSE OUT SERVICE REPORT. SERVICE CALL CANCELLED. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. FIELDS D1, D4 OF THE EMDR IS FOR ORIGINAL IABP SYSTEM 98; HOWEVER, THIS IABP WAS UPGRADED TO A CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V CATALOG#0998-00-3023-68 UDI# (B)(4), WHICH WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD DAMAGED SCREEN. THERE WAS NO PATIENT INVOLVED AND NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ROUTINE CHECK THAT SCREEN OF CS300 INTRA AORTIC BALLOON PUMP (IABP) WAS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN WAS DAMAGED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048929 ASSY,ENGLISH,DOMSTC,110V,SYS98 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0446-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.