MAUDE Adverse Event Report: DATASCOPE CORP. SYS 98 XT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0446-55
Medical Device Problem Codes	Component Incompatible (1108); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site name is (b)(6) a supplemental report will be submitted upon completion of our investigation.Cs100 upgraded from s98xt.
Event or Problem Description
It was reported that during routine check the cs100 intra-aortic balloon pump (iabp) unit shows low vacuum error.No patient involved.No one was harmed onsite.
Additional Manufacturer Narrative
Updated fields: h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11 corrected fields: d1, d4 (version or model, catalog, udi), h6 (medical device problem code).The udi was initially submitted as (b)(4); however, the correct udi is currently unknown.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse checked the machine and found the issue with manifold drive assembly.Replaced the drive manifold (d104-00-0018) provided by customer.Checked functionally found ok.Handed over the machine in good working condition.
Event or Problem Description
N/a.

• Brand Name: SYS 98 XT
• 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: 21592319
• Report Number: 2249723-2025-0001212
• Device Sequence Number: 12996551
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 0998-00-0446-55
• Device Catalogue Number: 0998-00-0446-55
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Patient Sex: Unknown