MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-67
Medical Device Problem Codes	Charging Problem (2892); Gas/Air Leak (2946); Overcorrection (3006); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) a supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that during check the counter-aortic cs300 intra-aortic balloon pump(iabp) does not hold the battery charge and reports maintenance code #3.There was no patient involved.
Additional Manufacturer Narrative
Corrected fields: e1(event site name,event site address), h6(medical device problem code) updated fields: b4,g3,g6,h2,h6(type of investigation, investigation findings, component codes, investigation conclusions),h11.A getinge field service engineer (fse) evaluated the unit for the reported malfunction.No problems were found regarding the duration and or operation of the batteries.To address the maintenance code, the fse cleaned the pressure transducers.During the functional tests, values outside the limits were detected regarding the seal of the valve group.The fse replaced the drive manifold assembly.Functional tests were performed successfully.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11 corrected data: h6 (component codes ).
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (type of investigation, medical device ¿ problem code, investigation findings, component codes, investigation conclusions).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 24368716
• Report Number: 2249723-2026-0001296
• Device Sequence Number: 9679214
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/15/2026; 04/15/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/08/2026; 04/15/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown