MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-45
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use, the cs100 intra-aortic balloon pump (iabp) unit had an alarm for excessively low negative pressure.Patient involved and there was no patient harm reported.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site postal code: (b)(6).The serial number for the medical device referred to in this medical device report has not been received, and therefore, no udi number can be provided.Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated fields - b4, b6, b7, d9, d10, g2, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.The customer replaced the unit and continued the treatment.There was no patient harm reported.Repair was performed by a third party.

• Brand Name: CS100 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: 24924957
• Report Number: 2249723-2026-0002373
• Device Sequence Number: 10275959
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: (01)10607567107790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2026

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
• Device Model Number: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 05/13/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/13/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown