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

Model Number	0998-00-3013-58
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site city- (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that screen of cs100 intra aortic balloon pump does not work.There was harm or injury reported to the patient.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit because the fse received information (the client doesn't inform us of their decisions).The customer cancel the notification, and they don't provide any explanations.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, b5, g3, g6, h2, h11.Corrected field- e1 (event site name and address).Due to character limitation, below fields are added from e1 event site name- (b)(6).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 22836861
• Report Number: 2249723-2025-0003517
• Device Sequence Number: 13117470
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: (01)10607567107622
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/08/2025

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: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 10/08/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKNOWN.
• Patient Sex: Unknown