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 Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that before use, the cs100 intra aortic balloon pump does not recognize ecg cable signal and monitor, it darkened without being able to see the parameters.There was no patient involvement and no injury reported.
Additional Manufacturer Narrative
Due to the character limit in the e1 section, the full initial reporter's name is:(b)(6).A supplemental report will be submitted upon the completion of investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6-type of investigation, investigation findings, investigation conclusion and h11.A getinge field service engineer (fse) checked the machine and cleaned the monitor connection connector contacts.By performing various functional tests with an ecg simulator, the ecg signal was always detected correctly.Repair completed.Functional tests performed with positive results.The equipment has been returned to the customer for clinical use.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6- investigation findings.
Event or Problem Description
N/a.

• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22015778
• Report Number: 2249723-2025-0002199
• Device Sequence Number: 8814654
• 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): 06/06/2025

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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 06/06/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/06/2025; 06/06/2025
• 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