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

Model Number	0998-00-3023-45
Medical Device Problem Codes	Leak/Splash (1354); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 event site name is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300 intra aortic balloon pump(iabp) had a loop leak alarm during use.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11, d9, h3,b5, h6 (type of investigation, investigation findings, component codes, medical device ¿ problem code , investigation conclusions) a getinge field service engineer (fse) evaluated the unit and identified that the safety disk values were outside factory specifications.In addition, the battery backup capacity was found to be degraded.The safety disk values (0997-00-0985-15) and battery (0146-00-0039) were replaced to correct the issue.Following repair, the unit underwent functional and safety testing, all of which passed per manufacturer specifications.Replaced parts were retained by the customer.
Event or Problem Description
It was reported by the customer that during use, the cs300 intra-aortic balloon pump (iabp) had a circuit leak alarm.The balloon was checked and found to have no abnormalities.Patient involvement was reported, however no patient harm or injury occurred, as the patient was transferred to another device to continue therapy.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 24838976
• Report Number: 2249723-2026-0002168
• Device Sequence Number: 15860887
• Product Code: DSP
• UDI-Device Identifier: 10607567108575
• UDI-Public: (01)10607567108575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 0998-00-3023-45
• Device Catalogue Number: 0998-00-3023-45
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/07/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/05/2026; 05/07/2026
• 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: UNKNOWN.
• Patient Sex: Unknown