MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-53
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had an auto fill failure.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 initial reporter: (b)(6).
Additional Manufacturer Narrative
A getinge field service engineer was sent to investigate the issue.After inspection the fse was not able to reproduce the autofill failure.The iabp passed all functional tests and was returned to the customer for use.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an auto fill failure.There was no patient harm reported.
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, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: 18846159
• Report Number: 2249723-2024-00939
• Device Sequence Number: 7757354
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: (01)10607567107745
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/23/2025

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-UC-3013-53
• Device Catalogue Number: 0998-UC-3013-53
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 04/09/2024; 01/23/2025
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/13/2024; 04/09/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown