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

Model Number	0998-00-3013-69
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitations in e1 - event site name - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that during use, the cardiosave intra-aortic balloon pump (iabp) displayed characters with faults on the screen when starting up the equipment.There was no harm or injury.
Event or Problem Description
It was reported by the customer that during use, the cardiosave intra-aortic balloon pump (iabp) displayed characters with faults on the screen when starting up the equipment.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b8, d9, g1, g3, g6, h2, h3, h6 (investigation type, investigation findings, investigation conclusion), h11.It was reported that during the inspection cs100 intra aortic balloon pump (iabp) had some characters with faults on the display.There was no patient involvement or adverse event reported.A getinge field service engineer (fse) was dispatched to inspect the unit.The fse opened the display and cleaned the board¿s contact terminals.Following this procedure, the equipment functioned normally and completed over two hours of cycling without any abnormalities.The unit was released for clinical use.
Event or Problem Description
It was reported that during the inspection cs100 intra aortic balloon pump (iabp) had some characters with faults on the display.There was no patient involvement or adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5, d10, h6 (health effect ¿ impact codes, investigation conclusions).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 22095065
• Report Number: 2249723-2025-0002394
• Device Sequence Number: 18157640
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/28/2025

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: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 12/28/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 12/19/2025; 12/28/2025
• 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.; UNKNOWN.
• Patient Sex: Unknown