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 Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a routine check, the cs300 intra-aortic balloon pump (iabp) displayed a ¿low battery¿ message and had insufficient battery backup.There was no patient involvement and no harm reported.A getinge field service engineer (fse) evaluated the unit.During the evaluation, the device was tested after disconnecting it from ac power and was found to switch off within approximately one minute.The fse determined that the battery was defective and was not providing adequate backup power.The battery requires replacement.
Additional Manufacturer Narrative
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: 50867290
• Report Number: 2249723-2026-0004407
• Device Sequence Number: 9224004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown