MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-53
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cs300battery goes from 100 percent to zero in five minutes.No patient involvement or harm reported.
Additional Manufacturer Narrative
Cs100 upgraded to cs300.A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
(b)(6).Updated fields: b4, b5, b6, b7, d8, d9, g3, g6, h2, h6 (investigation findings, type of investigation, investigation conclusions, component code), h11, e3.Corrected field: e1 (initial reporter, event site telephone).A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that they were not able to duplicate the issue.The batteries were replaced as a precaution.Device passed the performance and safety checks according to factory specifications.
Event or Problem Description
It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) battery goes from 100 percent to zero in five minutes.There was no patient involvement reported.
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11.Corrected field : g4 , b5.
Event or Problem Description
It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) battery goes from 100 percent to zero in five minutes.There was no patient involvement reported.

• Brand Name: CS100 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: 23901468
• Report Number: 2249723-2025-0005314
• Device Sequence Number: 10143884
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 04/08/2026; 04/22/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 04/08/2026; 04/22/2026
• 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