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 Codes	Inability to Auto-Fill (1044); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 during planned inspection by fse, the cs100 intra-aortic balloon pump (iabp) had odometer reading 4645 h pump inoperative.It did not reach the set vacuum values.There were few technical errors generated.Error #57, #62.The pump fails the following tests: autofill test, k6, k6a, k7, k8 leak test and pneumatic performance test.There was no patient involved.
Additional Manufacturer Narrative
Updated fields- b5, b4, e1, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.It was reported that during inspection, the cs100 intra-aortic balloon pump (iabp) was not able to reach the required vacuum values.There was no patient involvement or patient harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the device fails key pneumatic and calibration tests.The unit failed the autofill test as well as the k6, k6a, k7, k8 leak test.The fse stated that the unit does not meet vacuum and leak criteria and recommends to perform full diagnostic and root cause repair.There is currently no updates on if the repairs were conducted on the unit the record will be updated when this information becomes available in the future.
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11 , h6 ( investigation findings , investigation conclusions).Corrected field : e1 ( initial reporter).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the device fails key pneumatic and calibration tests.The unit failed the autofill test as well as the k6, k6a, k7, k8 leak test.The fse stated that the unit does not meet vacuum and leak criteria and recommends to perform full diagnostic and root cause repair.There is currently no updates on if the repairs were conducted on the unit the record will be updated when this information becomes available in the future.

• 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: 22899071
• Report Number: 2249723-2025-0003611
• Device Sequence Number: 8984896
• 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): 03/24/2026

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: 08/08/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 03/24/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 03/09/2026; 03/24/2026
• 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