MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-53
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cs100 upgraded to cs300.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine check cs300 had the display issue.Screen is showing bars on it no patient involvement.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h11.Corrected field: h11.A getinge field service engineer (fse) checked the display assembly and replaced the video receiver board (d670-00-0736) & pcb, inverter, dc to ac (d671-00-0230) to improve the symptoms.Return unit to customer for use.The failure analysis and testing dept.Received the following parts associated with this complaint: part number 0670-00-0736 pcb, color video receiver serial number (b)(6).Part number 0671-00-0230 inverter board dc to ac serial number (b)(6).These parts were received with a reported unit failure of - screen is showing bars.The failure analysis and testing dept.Performed a visual inspection and found the parts to be in good condition.The failure analysis and testing dept.Installed part number 0670-00-0736 pcb, color video receiver serial number (b)(6) and part number 0671-00-0230 inverter board dc to ac serial number (b)(6) into the cs300 test fixture serial number (b)(6) and tested the parts to factory specifications per the cs300 service manual part number 0070-00-0689 rev.W.After forty-five minutes of run-time the fat dept.Could not replicate the complaint of the screen showing bars.The parts passed testing.Retaining the parts in the fat dept.Per procedure number 0002-07-d008 rev.Au.
Additional Manufacturer Narrative
Updated fields: b4,d9, g3, g6, h2,h3, h6(investigation findings, type of investigation, investigation conclusions), h11 a getinge field service engineer (fse) checked the display assembly and replaced the video receiver board (d670-00-0736) & pcb,inverter, dc to ac (d671-00-0230) to improve the symptoms.Return unit to customer for use.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 23901454
• Report Number: 2249723-2025-0005310
• Device Sequence Number: 10116740
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2026

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/16/2026; 02/16/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/16/2026; 02/16/2026
• 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