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 Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a routine inspection, an air leak was found in the alarm loop of the cs300 intra-aortic balloon pump(iabp) device.There was no patient involved.
Additional Manufacturer Narrative
Due to characterization limit e1: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Due to characterization limit e1: event site phone number (b)(6).Updated fields: b4, e1 (initial reporter name initial reporter mail id), g3, g6, h2, h6(investigation type, investigation findings, investigation conclusion, component code), h11.It was reported that during routine inspection, the cs300 intra aortic balloon pump (iabp) was found to have an air leak in the alarm loop.There was no patient involvement or harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the device malfunctioned safety disk assy chinese and drive manifold was replaced.After replacement, all parameters of the device were normal, and it was put back into clinical use.
Event or Problem Description
N/a.

• 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: 24369256
• Report Number: 2249723-2026-0001299
• Device Sequence Number: 14680981
• 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
• Report Date (Section B): 03/10/2026

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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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
• Patient Sex: Unknown