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

Model Number	0998-00-3023-58
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Gas/Air Leak (2946); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during start-up the cs300 intra-aortic balloon pump (iabp) when accessing the device's service menu and viewing its logs, the 'cs300 *cardiac surgery biomed delivery' errors displayed.There was no patient involved.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields - b4, d9, g1(contact person ¿ mfg site), g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings, component code, investigation conclusions), h11 a getinge field service engineer (fse) inspected and observed intermittent failure of the drive transducer and manifold k6, k7, and k8.A final estimate had been submitted.Fse replaced valves and drive manifold.The equipment was ready for use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h6(problem code) (investigation conclusion).

• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21771499
• Report Number: 2249723-2025-0001598
• Device Sequence Number: 8263547
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: (01)10607567108339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 09/10/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/21/2025; 09/10/2025
• 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