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

Model Number	0998-00-3023-64
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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 that, the cs300 intra-aortic balloon pump (iabp) unit has error 50 motor speed out of specification.There was no patient involvement.
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 codes, investigation conclusions), h11 corrected fields: d4(unique identifier (udi) #), h8 a getinge field service engineer (fse) noticed that the motor was not working very well.Fse changed the motor power supply board (0671-00-0004) and tested the device.Functional device according to the manufacturer's standard.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.The failure analysis and testing dept.Received part number 0671-00-0004 pcb motor control serial number (b)(6) with a reported unit failure of error code 50.The failure analysis and testing dept.Performed a visual inspection and observed a slight amount of a white residue under the connectors, which is consistent with saline.Please see attachment.Probable cause of error code 50 was the saline spill on the board.Retaining the board in the fat per procedure number (b)(4).
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2,h11, d9.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20003101
• Report Number: 2249723-2024-03363
• Device Sequence Number: 7414814
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308(21)S805630J1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/29/2025

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: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 04/15/2025; 04/29/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 01/31/2025; 04/28/2025; 04/29/2025
• 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