MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-31
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site name is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) erroneous communication packets between the display and exec board which suggests a bad connection/corrupt video generator board or damaged coiled cord.No one is harmed.Connection fault 78.For technical error 63, the errors are due to erroneous communication packets between the display and exec board which suggests a bad connection, faulty video generator board, or damaged coiled cord.No patient, no harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (investigation findings, investigation type, investigation conclusion), h11.Corrected fields: h6 (medical device ¿ problem code).It was reported that when turned on, the cardiosave intra-aortic balloon pump (iabp) had a communication issue with main display.There was no patient involvement reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reviewed the technical logs from the device and discovered multiple errors that indicated the issue was with the video generator board (0670-00-1182).The faulty part was replaced and the new board was updated to the latest software revision d.01.The unit passed all the functional and safety tests as per factory specifications.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 23658771
• Report Number: 2249723-2025-0004848
• Device Sequence Number: 21345944
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: (01)10607567109053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112372
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2026

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: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/01/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown