MAUDE Adverse Event Report: Datascope Corp. CS100 Intra-Aortic Balloon Pump, Chinese, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3013-45
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-use testing, the cs100 intra-aortic balloon pump (iabp) safety disk could not be secured.Date of event is unknown.No patient involvement.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that guide block securing the safety disk was broken and detached.Guide block was replaced.Product passed all functional and safety tests per manufacturer specifications.The equipment has been delivered to the customer and is ready for clinical use.
Additional Manufacturer Narrative
E1 - (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CS100 Intra-Aortic Balloon Pump, Chinese, 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: 50813852
• Report Number: 2249723-2026-0004351
• Device Sequence Number: 10158099
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: (01)10607567107790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031636
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/18/2026
• 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