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	Inability to Auto-Fill (1044); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due character restriction on field e1: event site name: getinge group japan co., ltd.Tokyo office.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra aortic balloon pump (iabp) had frequent automatic refill errors.There were no adverse consequences to the patient reported.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for eval), e1 (initial reporter), g1 (event site telephone), g3, g6, h2, h3, h6 (medical device problem code, type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: b6, b8, e1 (event site telephone).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they were unable to successfully reproduce the same errors after multiple attempts.The unit passed all safety and functional tests before being returned to clinical use.

• 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: 20929836
• Report Number: 2249723-2024-0005047
• Device Sequence Number: 8320450
• 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
• Report Date (Section B): 02/23/2026

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: 0998-00-3013-65
• 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: 11/24/2024
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/23/2026
• 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