MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-58
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation.Initial reporter full name: maquet portugal lda.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during preventive maintenance cs300 intra-aortic balloon pump (iabp) had pressure transducer drive manifold problem.There was no patient involvement.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h3, h6 (component code, investigation findings, investigation conclusions, type of investigation), h11.A getinge field service engineer (fse) evaluated the device and several faults were detected.Fse replaced pressure sensors x1 and x2 faulty (0682-00-0076-01), drive assembly (0104-00-0018), fill manifold (0104-00-0023).The following was also missing: support (iv pole) (0436-00-0199), power cable (0012-00-0886-02), bag with doppler (0154-01-0001).The material to replace and replenish was ordered.On 5-02-2025 replacement of identified components and calibration of all equipment.Verification, preparation of service protocol and functional tests.Operational equipment.Unit returned for clinical use.

• Brand Name: CS300 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: 21398089
• Report Number: 2249723-2025-0000726
• Device Sequence Number: 20777237
• Product Code: DSP
• UDI-Device Identifier: 10607567108759
• UDI-Public: (01)10607567108759
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K063525
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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-3023-58
• Device Catalogue Number: 0998-UC-3023-58
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown