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

Model Number	0998-00-3013-67
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fields d1, d4 of the emdr is for original iabp cs100; however this iabp was upgraded to a cs300.Due to character limitation, below field are added from e1: event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs300 intra aortic balloon pump (iabp) was giving error alarm 52 at power on.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4, b5, g3, g6, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected fields - h6 (medical device ¿ problem code).A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse replaced the front-end board (0670-00-0668).Pressure transducer calibration was performed with atmospheric, shuttle and drive side with relative offset adjustment.Diagnostic and functional tests were performed.Operation tests were performed with positive results.
Event or Problem Description
It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) had an electrical test fail # 52 when powering on.There was no patient involvement.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 22662565
• Report Number: 2249723-2025-0003242
• Device Sequence Number: 3677720
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/22/2025

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/22/2025
• 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
• Patient Sex: Unknown