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	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use, the cs100 intra-aortic balloon pump (iabp) malfunctioned.Unit displayed autofill failure alarm.User replaced the unit with another one.Patient was involved.There was no patient harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the fault was caused by insufficient negative pressure leading to an automatic inflation failure, requiring the replacement of the 5000-hour maintenance kit.Parts were replaced.Product passed all functional and safety tests per manufacturer specifications.Unit was delivered to the customer.
Additional Manufacturer Narrative
E.(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: 50770753
• Report Number: 2249723-2026-0004300
• Device Sequence Number: 18498038
• Product Code: DSP
• UDI-Device Identifier: 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown