MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-55
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp)¿s damaged batteries were replaced during a technical inspection.There was no patient involved.
Additional Manufacturer Narrative
Due to characterization limit e1: initial reporter name: (b)(6).Updated fields: b4,g3,g6,h2,h6(type of investigation, investigation findings, investigation component code ,conclusions), h11.Corrected fields: e1 (initial reporter name), e2, e3, e4.The (fse) reported that the two batteries were replaced.The unit passed electrical safety tests.And functional tests were passed.The safety disk was replaced as part of preventative maintenance.The unit passed functional tests and was confirmed to be operational.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL
• 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: 24685673
• Report Number: 2249723-2026-0001856
• Device Sequence Number: 9653393
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: (01)10607567107875
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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-UC-3013-55
• Device Catalogue Number: 0998-UC-3013-55
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 05/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/08/2026; 05/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown