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

Model Number	0998-00-3023-61
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Device Problem Term/Code Not Available (3191); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1, initial reporter full name: (b)(6).Full event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported before use that a cardiosave intra-aortic balloon pump (iabp) had unspecified malfunction.No patient was involved.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9, g1, g3, g6, h2, h3, h6 (problem code, type of investigation, investigation findings, investigation conclusion), h11.Corrected fields: g4.A getinge field service engineer (fse) found system failure and fault log 61.Fse checked the system fault with continuous whistle at power on.Troubleshooting carried out at our laboratory, front end board replacement, calibration of all pressure transducers, diagnostic and functional tests, repair completed.Function tests performed with positive results.The fault did not cause damage/inconvenience to operators/patients or delays in procedures.
Event or Problem Description
It was reported before use that a cardiosave intra-aortic balloon pump (iabp) had fault code 61 and system failure alarm.No patient was involved.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: lori gosselin ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21882490
• Report Number: 2249723-2025-0001908
• Device Sequence Number: 12704201
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 07/17/2025

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown