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 Codes	Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event initially occurred on (b)(6) 2023, the repair quotation was given in 2023 but customer has not responded any.So now in (b)(6) 2025, for same device the repair quote along with preventive maintenance quote was given to customer and customer accepted only preventive maintenance quote.A supplemental report will be submitted after the completion of investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) battery indicator is not functional.There was no injury reported.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.A getinge field service engineer (fse) found the power supply need to be replaced.The customer never followed up on the repair quote.Preventive maintenance was carried out in december 2025.As no further information is available at this time, this complaint will be closed.Should additional information become available, the investigation will be updated accordingly.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:b3,b4,b5,b6,b7,d5,d9,d10,e1(initial reporter)(event site mail),e2,e3,e4,g3,g6,h2,h3,h6(problem code, type of investigation, investigation findings,component code, impact code, conclusion),h11 due to character limit: e1(initial reporter)- (b)(6).It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) had battery indicator, dead battery light.The fse found the power supply need to be replaced.The customer never followed up on the repair quote.Preventive maintenance was carried out in december 2025.As no further action is required at this time, this complaint will be closed.Should additional information become available, the investigation will be updated accordingly.
Event or Problem Description
It was reported during preventive maintenance the cs300 intra-aortic balloon pump (iabp) battery indicator is not functional.No patient involved.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11 corrected fields: h6(investigation findings).
Event or Problem Description
N/a.

• 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 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: 23467029
• Report Number: 2249723-2025-0004556
• Device Sequence Number: 18629391
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2026

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: Other
• Device Model Number: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/17/2026; 03/10/2026; 03/25/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 03/05/2026; 03/15/2026; 03/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; UNKNOWN.
• Patient Sex: Unknown