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	Electrical /Electronic Property Problem (1198); Decrease in Pressure (1490); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during use the cs300 intra aortic balloon pump had displayed low vacuum alarm followed by electrical code error 50.There was no injury or threat to the patient or other person.Use another device.
Additional Manufacturer Narrative
Due to character limit in the e1 section the full initial reporter names are (b)(6).A supplemental report will be submitted upon the completion of investigation.
Additional Manufacturer Narrative
Updated fields - b4, b5, d8, g1 (contact person ¿ mfg site), g3, g6, h2, h3 , h6 (type of investigation, investigation findings, component codes , investigation conclusions), h11.Corrected fields - e1 (event site postal code) was inadvertently submitted.A getinge field service engineer (fse) was dispatched to evaluate the unit.According to the inspection the probable root cause of the defect is motor control board defect.Method of eliminating the defect: inspection of the device is necessary and then replacement of the defective component.Waiting for the customer for accepting the quotation.
Event or Problem Description
It was reported by customer that during use the cs300 intra aortic balloon pump had displayed low vacuum alarm followed by electrical code error 50.There was no injury or threat to the patient or other person.Use another device cs100 pump to continue therapy.
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11 , h6 ( medical device ¿ problem code ,investigation findings , component codes ).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(investigation findings, component codes), h11 a getinge field service engineer (fse) checked the device and performed to rule out an electronic board error.Board error ruled out.On 30.07.2025, after consultation with the customer, the compressor from the customer's cs100 was tested.After using the compressor, the device was functional again.Compressor defect confirmed.After agreement with the customer, the compressor was left in the cs300 device, a safety and functional check of the device was performed according to the valid service manual and according to the manufacturer's recommendations.On 04.08.2025, a price quote for the compressor replacement was sent.On 09.10.2025, the service report was closed due to the previous non-acceptance of the price quote for the repair.In future if we receive any repair information will reopen and update the investigation.

• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22393942
• Report Number: 2249723-2025-0002851
• Device Sequence Number: 9126954
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 11/11/2025

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: 0998-00-3023-61
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/30/2025; 11/11/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/06/2025; 11/11/2025
• 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