MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-57
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	10/05/2024
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 during corrective maintenance, the cs300 intra-aortic balloon pump (iabp) showed error code 91 when the pc board was replaced and the pc board is damaged.There was no patient involvement.
Additional Manufacturer Narrative
It was reported that during corrective maintenance by (b)(6) personnel powered on cs300 intra-aortic balloon pump in clinical mode the unit displayed the following message on the screen "91 front end hc11 rom test.The client was quoted the front board reference 0670-00-0668 for the console, since the original board that the client's console has sulfation, when installing the new board, the equipment throws errors 91 and 26 and it is confirmed that it arrived defective.Replaced the front-end board", after installing the front-end board: electrical test fail codes: #91.This is the error description according to the service manual.Front end board was replaced with a new one, and the problem was corrected.The following spare parts are installed: motor control board (da0671-00-0004), k6a vent valve (da0119-00-0170), purge valve (da0104-00-0026) and console front card (da0670-00-0668).All functional and safety checks performed to meet factory specifications.Equipment out of service.No other information is available so closing this complaint, will reopen and update it in case if we receive some new information in future.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V
• 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: 20535009
• Report Number: 2249723-2024-0004387
• Device Sequence Number: 15508612
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: (01)10607567108254
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• 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: 10/05/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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