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)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit e1 contact person name- (b)(6).This is a sys98 upgraded to cs300, therefore udi and other product specific details provided are of cs300 pump.Supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine check 98xt upgraded into cs300 intra aortic balloon pump (iabp), the display was not working properly.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9 (device available for eval), g1(contact person ¿ mfg site), g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: e1(event site telephone).A getinge field service engineer (fse) was dispatched at the site and found its shadow screen coming on display at the time of main switch on.Then checked display board along with video generator boards and its all connectors connection properly & refitted with circuit board once again properly.Then checked white ribbon cable connector properly & found its ok.Then checked it¿s all safety test & found all parameters are passed successfully within range.Then machine connected with balloon and found its working ok.After all handed over to the department in good working condition.
Event or Problem Description
N/a.

• 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: 21932717
• Report Number: 2249723-2025-0002006
• Device Sequence Number: 15639108
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 04/17/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown