MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-68
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 for event site name and event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) was down with screen problem and shaking.There was no patient harm reported.
Additional Manufacturer Narrative
Updated fields- b4, d9, g1 (contact person ¿ mfg site), e3, g3, g6, h1 h2 , h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.It was reported that the cs300 intra aortic balloon pump (iabp) was experiencing a distorted display.There was no adverse event reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse troubleshoot the display and narrowed down the issue to the display and pcb, keypad controller.Both were replaced and the unit passed all functional and safety tests and was cleared for clinical use.

• Brand Name: CS300 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: 23082511
• Report Number: 2249723-2025-0003908
• Device Sequence Number: 18594972
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063525
• 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
• Report Date (Section B): 12/31/2025

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: 0998-00-3023-68
• Device Catalogue Number: 0998-00-3023-68
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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