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	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation due to character limitation; below field are added from e1: event site full name: (b)(6).Event site address: (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a unexpected shutdown.
Additional Manufacturer Narrative
Updated fields:b3,b4,b5,b6,b7,d5,d9,d10,e1(initial reporter)(event site mail),e2,e3,e4,g3,g6,h2,h3,h6(type of investigation, investigation findings,component code, impact code, conclusion),h11.Getinge field service engineer (fse) the cs100 intra aortic balloon pump (iabp) was shutting down unexpectedly.A technical inspection of the equipment revealed that preventive maintenance was overdue.The equipment has reached its operating hours limit, requiring replacement of critical components for continued safe operation.The fse evaluated the unit and replaced the 5000h kit and the safety disk.The hose was replaced as requested in the previous quote, all tests were performed and approved.The unit was returned to the customer.There was no patient involved.
Event or Problem Description
It was reported during routine check by getinge fse, that the cs100 intra-aortic balloon pump (iabp) had an unexpected shutdown.No patient involved.

• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22158023
• Report Number: 2249723-2025-0002506
• Device Sequence Number: 12579235
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: Other
• Device Model Number: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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