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 Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported by customer that the cardiosave intra aortic balloon pump had a black circle on screen.No one was harmed onsite.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d9, d10, g1 (initial reporter name, event site email, event site address), e3, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, health effect ¿ impact codes, investigation conclusions), h11.A getinge field safety engineer (fse) was dispatched at site to evaluate the unit.Fse checked machine, he was able to reproduce the reported issue and replaced the faulty display top lcd.Fse performed the full testing and calibrations as per specifications.Also performed the electrical safety testing as per standard.Device is working within specifications.
Event or Problem Description
It was reported by customer that during routine check, cardiosave intra-aortic balloon pump (iabp) had black circle on screen.There was no patient involvement.

• 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: 22693843
• Report Number: 2249723-2025-0003328
• Device Sequence Number: 8306925
• 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): 11/24/2025

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: 0998-00-0800-31
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/02/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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