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

Model Number	0998-00-3013-64
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer during routine check that the cs100 intra-aortic balloon pump (iabp) unit had ecg reading problem.There was no patient involvement reported.
Additional Manufacturer Narrative
Due to character limitation in e1 for initial reporter, the full initial reporter is (b)(6).Additional telephone number is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: g6, h2.Corrected fields: e3, h6 component code, h11.Note: original iabp cs100; however, this iabp was upgraded to a cs300 intra-aortic balloon pump.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(investigation type, investigation findings, investigation conclusion, component code), h11.It was reported that during routine check, the cs300 intra aortic balloon pump (iabp) had an ecg reading problem.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 unit was replaced as a precaution.The ecg input and output, as well as pressure, were checked using a minisim test device.No issues were found with the device.The device is functioning according to the manufacturer's protocol.The unit passed all functional and safety checks and was cleared for service.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 24340527
• Report Number: 2249723-2026-0001247
• Device Sequence Number: 9773280
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: (01)10607567107509
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/28/2026; 04/01/2026
• Initial Report FDA Received Date: 02/14/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/01/2026
• 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