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); Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra aortic balloon pump (iabp) displayed an automatic balloon charging failure message during system testing.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.It was reported by the customer that before use, the cs100 intra-aortic balloon pump (iabp) had a fault #57 (autofill failure).There was no patient involvement reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The user reported that upon starting the tests, it displayed the message "automatic charging failure" without any trigger signal.Functional tests were performed without detecting any anomaly.Equipment is operational.The fse could not confirm the issue.No parts were replaced.The unit passed all functional and safety checks to factory specification.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to characterization limit e1: contact number: (b)(6).Updated fields; b4, g3, g6, h2, h11.Corrected fields: b5, e1 initial reporter name and mail id, h6 (medical device problem, health effect).
Event or Problem Description
It was reported that the cs100 intra aortic balloon pump (iabp) displayed an automatic balloon charging failure message during system testing.There was no patient involved.
Event or Problem Description
It was reported that the cs100 intra aortic balloon pump (iabp) displayed an automatic balloon charging failure message during system testing.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 investigation type.The user reported that upon startup, the cs100 displayed the message ¿automatic charging failure¿, without any trigger signal.There was no patient involvement reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse confirmed fault 57 had occurred, corresponding to autofill failure.However, functional tests were performed without detecting any anomaly.The fse could not reproduce the autofill failure.No parts were replaced.The unit passed all functional and safety checks to factory specification.

• 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: 24276497
• Report Number: 2249723-2026-0001111
• Device Sequence Number: 9802741
• 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,Followup
• Report Date (Section B): 03/23/2026

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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/23/2026; 03/31/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/11/2026; 03/23/2026; 03/31/2026
• 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