MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-65
Medical Device Problem Codes	Gas/Air Leak (2946); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 for event site name, event site name - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use, the cs100 intra-aortic balloon pump (iabp) had rapid gas leak alarm.There was no patient harm reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: e1 (initial reporter).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings and investigation conclusions), h11.A getinge fse was dispatched to evaluate the unit he states a rapid gas leak alarm occurred.The equipment was replaced due to the rapid gas leak alarm (the balloon continued to be used and there were no problems) after the replacement, the hospital staff performed a running test and confirmed that an alarm of "insufficient negative pressure in the compressor" occurred.Based on the condition of the equipment, it was explained to the hospital staff that damage to the internal parts of the compressor (connectors, membranes, etc.) was suspected.It was informed that the cs100 service has been discontinued in japan, and it was confirmed that the equipment would not be repaired and would not be used in the future.
Event or Problem Description
It was reported that during use, the cs100 intra-aortic balloon pump (iabp) had rapid gas leak alarm and displayed insufficient negative pressure of the compressor message.There was no patient harm reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 22148803
• Report Number: 2249723-2025-0002495
• Device Sequence Number: 18229635
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/04/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/05/2025
• 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: UNKNOWN.
• Patient Sex: Unknown