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

Model Number	0998-00-3013-55
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a routine check, a low vacuum alarm was detected during a balloon test of the cs100 intra-aortic balloon pump (iabp).There was no patient involvement and no harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that upon opening the drive manifold, it was found that the contacts of the solenoid valve assembly were contaminated with carbon deposits from the pressure-generating rubber of the pump unit.This caused the contacts to not close properly, resulting in a low vacuum alarm.The fse cleaned the contacts of solenoid valves k7 and k8.The unit passed all functional and safety tests to manufacturer specifications.However, replacement of the 5,000h maintenance kit is recommended, as the device has exceeded 5000 hours of use without its replacement.It was noted that the pressure-generating rubber component which has deteriorated and is accumulating soot is part of the 5,000h maintenance kit.Additionally, the battery is showing signs of deterioration, and its replacement is recommended.A quote has been provided to the customer and is pending acceptance.

• Brand Name: CS100 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: 50751974
• Report Number: 2249723-2026-0004268
• Device Sequence Number: 13071790
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Other
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown