MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-45
Medical Device Problem Codes	Decrease in Pressure (1490); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event, a follow up report will be submitted.Event site name: (b)(6) hospital.Event site address: (b)(6).
Event or Problem Description
It was reported that during pre use testing, the cs100 intra-aortic balloon pump (iabp) malfunctioned.Negative pressure was reported too low.No patient and no harm reported.
Event or Problem Description
It was reported that during pre use testing, the cs100 intra-aortic balloon pump (iabp) malfunctioned.Negative pressure was reported too low.There was no patient involved.
Additional Manufacturer Narrative
Due to character restriction in block e1.E1 event site telephone is: (b)(6).Updated fields: b4, b5, b6 , b7,d8, d9, g3, g6, h2, h6(investigation findings, type of investigation, investigation conclusions), h11 , d3 , d5 , d10 , e2 , e3 , e1 (initial reporter , event site telephone) , g2 , g7 corrected field : h6 ( medical device ¿ problem code ).A getinge field service engineer (fse) inspected the unit and replaced the drive manifold.After the replacement, the unit was tested and found to be functioning normally.The unit was returned to the customer for use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
• 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: 24858040
• Report Number: 2249723-2026-0002253
• Device Sequence Number: 18770978
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: (01)10607567107790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/02/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown