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 Codes	Inability to Auto-Fill (1044); Decrease in Suction (1146)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 event site name (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had an autofill failure and low vacuum level.
Event or Problem Description
It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) had an autofill failure and low vacuum level.There was no patient involved.
Additional Manufacturer Narrative
Corrected data: b5, b6, b7, d10, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10.A getinge field service engineer (fse) evaluated the unit and adjusted the compressor pressure heads pressure.All functional and safety checks performed to meet factory specifications.The unit was returned for clinical use.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).

• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19031025
• Report Number: 2249723-2024-01368
• Device Sequence Number: 20874884
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: (01)10607567107622(21)SA102273-I7
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 05/22/2024; 01/24/2025
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/08/2024; 05/22/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown