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	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name(b)(6).Additional point of contact-(b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that before use by customer, cs100 intra-aortic balloon pump (iabp) not switching on.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected fields: e3.
Additional Manufacturer Narrative
Updated fields: b4, d1, d4 (model number, udi number, cataloge number), d9, g3, g6, h2, h3, h6(investigation type, investigation findings, investigation conclusion, component code), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that after checking the unit it was found that the unit was switching on properly, the fse noticed that the battery backup was low.After charging the battery, the unit was found to pass all parameters.The fse recommended to replace the batteries for better performance as the current ones were found to have a run time of less than 60 minutes.The customer decided to not replace the battery stating that the unit is working fine.

• 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: 23905573
• Report Number: 2249723-2025-0005378
• Device Sequence Number: 21338227
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: (01)10607567107875
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

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-UC-3013-55
• Device Catalogue Number: 0998-UC-3013-55
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 02/04/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/04/2026; 02/04/2026
• 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