MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-69
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1, full event site name: (b)(6), full event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) had vacuum loss.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9, g3, g6, h2, h3, h6 (health effect ¿ clinical code, health effect ¿ impact codes, type of investigation, investigation findings and investigation conclusions), h11 corrected fields: e1 (event site mail).A getinge fse was dispatched to evaluate the unit.He states, a new inspection was performed on the cs100 model bia as requested and it has not shown any abnormality in its operation to date.Tests were performed in service mode and all parameters are in accordance with those established by the factory, as shown in the attached photo, the equipment stayed cycling with the simulator for more than 4 hours without any intercurrences.The equipment is released for use.
Event or Problem Description
It was reported that during routine check up, the cs100 intra-aortic balloon pump (iabp) had vacuum loss.There was no patient involvement.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21984043
• Report Number: 2249723-2025-0002139
• Device Sequence Number: 8480149
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• 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): 06/18/2025

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: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/18/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/11/2025; 06/18/2025
• 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