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

Model Number	0998-00-3013-67
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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) had display image anomaly, unstable vision before use.There was no patient involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11 a getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that cleaning contacts on the control panel resolved the reported issue.Functional tests were performed successfully.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (medical device ¿ problem code, investigation findings).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 24762398
• Report Number: 2249723-2026-0001987
• Device Sequence Number: 10299761
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/07/2026; 04/15/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/09/2026; 04/15/2026
• 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: N/A.
• Patient Sex: Unknown