MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, English, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-55
Medical Device Problem Codes	Device Alarm System (1012); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during routine check, the cs300 intra-aortic balloon pump (iabp) had no battery back up.There was no patient involvement, no harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that unit drained batteries immediately, after replacing batteries additional low battery alarm was present.Power supply board was found to be suspected and it needs to be replaced for further diagnostics.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CS300 Intra-Aortic Balloon Pump, English, 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: 50878046
• Report Number: 2249723-2026-0004413
• Device Sequence Number: 9314363
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sex: Unknown