MAUDE Adverse Event Report: DATASCOPE CORP. CS100 UTS INTRA-AORTIC BALLOON PUMP ENG DOMSTC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-83
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported during a routine check performed by a getinge field service engineer (gfse), the cs100 intra-aortic balloon pump (iabp) external pressure input is not possible.There was no patient involvement.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4,d8,d9,g1,g3,g6,h2,h3,h6( type of investigation.Investigation findings, component code, investigation conclusion) h11.Corrected fields: d1, d4(model number, udi, catalog number).A getinge field service engineer (fse) evaluated the unit and resolved the issue by replacing d012-00-0765 cbl assy external monitor conn.Fse then tested the safety and functionality as per factory specifications and iabp was then returned to customer for clinical use.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit and resolved the issue by replacing cbl assy external monitor conn.Fse then tested the safety and functionality as per factory specifications and iabp was then returned to customer for clinical use.The following investigation was performed by technician of the maquet failure analysis and testing dept.(b)(6) ,the failure analysis and testing dept.Received part cable assy, external monitor connector serial number n/a with a reported unit failure of external pressure is not possible.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed the part cable assy, external monitor connector into the cs100 test fixture and tested the cable assembly to factory specifications per the cs100 service manual part the fat dept.Did not receive an external pressure signal when the cable was tested.The fat dept.Was able to replicate the failure of external pressure is not possible experienced by the customer.The cable failed testing.Wear and tear of the connector may be probable cause of failure.Retaining the cable in the fat dept.Per procedure.
Event or Problem Description
N/a.

• Brand Name: CS100 UTS INTRA-AORTIC BALLOON PUMP ENG DOMSTC
• 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: 18040603
• Report Number: 2249723-2023-04672
• Device Sequence Number: 7344675
• Product Code: DSP
• UDI-Device Identifier: 10607567107400
• UDI-Public: (01)10607567107400(21)SA03936-F5
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2025

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: Other
• Device Model Number: 0998-00-3013-83
• Device Catalogue Number: 0998-00-3013-83
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/02/2024; 01/29/2025; 02/21/2025
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 10/08/2024; 02/19/2025; 02/21/2025
• 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