MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, FRENCH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-64
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 that during routine check by customer, the cs300 intra-aortic balloon pump (iabp) malfunctioned.User reported purge leak alarm, which occurred only once.There was no patient involvement reported.
Additional Manufacturer Narrative
Updated fields:b4,b6,b7,d9,d10,e2,e3,e4(initial reporter,event site telephone),g3,g4,g6,g7,h2,h3,h6(type of investigation,investigation findings,investigation conclusions),h11.Corrected fields: d1,d4(version or model #,catalog #,unique identifier (udi) #),e4(event site name,event site address,event site city,event site postal code(postal code was incorrectly sent in initial mdr)),g2.Customer removed the condensation in the tubing according to guidance from the phone customer support.After that, the alarm didn't occur again.A getinge field service engineer (fse) evaluated the unit and found no anomalies (leak test).All functional and safety test passed.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, FRENCH,NON-UTS,INTL
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 24444463
• Report Number: 2249723-2026-0001431
• Device Sequence Number: 10307826
• Product Code: DSP
• UDI-Device Identifier: 10607567108797
• UDI-Public: (01)10607567108797
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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
• Device Model Number: 0998-UC-3023-64
• Device Catalogue Number: 0998-UC-3023-64
• Device Lot Number: N/A- NOT REQUIRED FOR HARDWARE
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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