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

Model Number	0998-00-3013-65
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the cs100 intra-aortic balloon pump (iabp) had auto-fill error during user checking.There was no patient involved.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated: b4, d10, g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions) and h11.A getinge field service engineer (fse) stated the customer retested it and it worked without any problems.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21503086
• Report Number: 2249723-2025-0000960
• Device Sequence Number: 4400856
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown