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 Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during use the cs300 intra-aortic balloon pump (iabp) shut off.A patient was involved; however, no harm was reported.Following the failure, the iabp was exchanged and therapy was continued using another pump.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that unit shut off and would not turn back on.Plugged unit into ac power, unit came back on and batteries were almost completely depleted after one hour of use.Replaced batteries and charged batteries.Product passed all functional and safety tests per manufacturer specifications.Returned unit to service.
Event or Problem Description
It was reported by the customer that during use the cs300 intra-aortic balloon pump (iabp) shut off.No harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that unit shut off and would not turn back on.Plugged unit into ac power, unit came back on and batteries were almost completely depleted after one hour of use.Replaced batteries and charged batteries.Product passed all functional and safety tests per manufacturer specifications.Returned unit to service.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50727675
• Report Number: 2249723-2026-0004249
• Device Sequence Number: 10599604
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: (01)10607567107882
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown