MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, English, 110V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-53
Medical Device Problem Codes	Battery Problem (2885); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction field: d5, d10, e2, g2, g7 updated fields: b4, d9 (return to manufacture date), g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions, component code), h11 a biomed tech was dispatched to evaluate the unit.The biomed tech reported that failed the battery run time test at 44 min.The run time spec is 135 min.The biomed tech replaced the batteries 2x.The unit passed all functional and safety tests per factory specifications and the unit was returned to the customer.The defective battery was received for evaluation by the getinge failure analysis and testing dept.The following investigation was performed by carl famulare, technician of the maquet failure analysis and testing dept.The failure analysis and testing dept.Received part battery sealed lead acid 12v with a reported unit failure of short battery run time, not holding full charge.Please note this part number is a quantity of two batteries.The failure analysis and testing dept.Conducted a visual inspection and found the parts to be in good condition.The failure analysis and testing dept.Installed battery sealed lead acid 12v into the cs300 test fixture and tested the to factory specifications per the cs300 service manual part the fat dept.Was able to replicate the complaint of the short battery run time 44 minutes.The factory specification for battery run time is 135 minutes.The batteries failed testing.Retaining the batteries in the fat dept.Based on the fse investigation and the investigation of the returned component - the effect of battery will not charge or battery short run time on the cs300 is confirmed.

• Brand Name: CS300 Intra-Aortic Balloon Pump, English, 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 50579869
• Report Number: 2249723-2026-0004131
• Device Sequence Number: 9891045
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: (01)10607567107882
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2008
• 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: Unknown
• Patient Sex: Unknown