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

Model Number	0998-00-3013-68
Medical Device Problem Codes	Inability to Auto-Fill (1044); Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11.Corrected field: b5 , h6 (medical device ¿ problem code, component codes, investigation conclusions).
Event or Problem Description
It was reported that during initial tests, the cs100 intra-aortic balloon pump (iabp) balloon failed during automatic filling.There was no patient involvement reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by user that during initial tests the cs100 intra-aortic balloon pump (iabp) had a system failure and balloon failed to load automatically.No patient involved.
Additional Manufacturer Narrative
Updated fields: b4, d4 udi number, e1 initial reporter name , event site telephone and mail id, g2, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected fields: e1 event site name a getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the connector of the bia filling line was found to be broken.The wheels of the device were also damaged due to use.The connector was replaced, but it was verified that there are no more wheels in stock at the factory to supply.The unit passed all functional and safety checks to factory specification and was cleared for use.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 23505398
• Report Number: 2249723-2025-0004626
• Device Sequence Number: 18401668
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: (01)10607567107691
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 01/06/2026

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: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/06/2026
• Initial Report FDA Received Date: 11/08/2025
• Supplement Report FDA Received Date: 01/01/2026; 01/06/2026
• 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