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

Model Number	0998-00-3013-67
Medical Device Problem Codes	Contamination (1120); Electrical /Electronic Property Problem (1198); Device Contamination with Body Fluid (2317); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions, initial reporter: (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 routine check, cardiosave intra-aortic balloon pump (iabp) had electrical error 50.There was no patient involvement reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (medical device ¿ problem code, investigation findings).
Additional Manufacturer Narrative
Updated fields: b4, b5, d9(device available for eval), e1(initial reporter), g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, investigation conclusions), h11 corrected fields: e1(event site name), due to character limit in e1 (event site name: (b)(6) hospital).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, troubleshooting performed, motor control board and compressor replaced.Traces of liquid found inside.Functional and diagnostic tests performed.
Event or Problem Description
It was reported by the customer that during routine check, cardiosave intra-aortic balloon pump (iabp) had electrical test error# 50.There was no patient involvement reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 23289435
• Report Number: 2249723-2025-0004283
• Device Sequence Number: 5507382
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 11/25/2025

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 11/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025; 11/25/2025
• 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