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	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 for initial reporter, the full initial reporter is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer during use that the cardiosave intra-aortic balloon pump (iabp) unit had intermittent green screen.There was patient involvement but no harm reported.
Additional Manufacturer Narrative
Updated fields: b4,d9(return to mfg date),g3,g6,h2,h6(type of investigation,investigation findings,investigation conclusions), h11.A getinge field service engineer(fse) evaluated the unit and identified an intermittent green top screen display and error 63.The video generator board and the display top lcd assembly were replaced.The touchscreen was calibrated, and a full functional check and electrical safety testing were performed.All tests passed successfully.The failure analysis and testing department received the video generator,top lcd display with a reported unit failure of intermittent top green screen.The fat dept.Performed a visual inspection of all components received and confirmed that no physical damage or abnormalities were observed.The failure analysis and testing dept.Installed parts video generator and top lcd display in the cardiosave test fixture and tested jointly and separately to factory specifications.The functional testing was performed for approximately three (3) hours.During this evaluation, the fat dept.Was unable to reproduce the reported failure.Retaining the parts video generator and top lcd display.
Event or Problem Description
N/a.

• 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: 24387270
• Report Number: 2249723-2026-0001338
• Device Sequence Number: 16012635
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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: UNKNOWN.
• Patient Sex: Unknown