MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID - TYPE "N" PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-36
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cardiosave intra-aortic balloon pump (iabp) does not finish its initialization, the screen keeps trying to communicate with the execute board and fails in sequence after 3 attempts, characters are disappearing on the display.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.(b)(6).
Event or Problem Description
It was reported by getinge technician that the cardiosave intra aortic balloon pump (iabp) had an issue in which the system failed to complete its initialization sequence during a routine check.The screen repeatedly attempted communication with the execute board and failed after multiple attempts, with characters intermittently appearing on the display.No patient involvement.
Additional Manufacturer Narrative
Updated fields:b4,b5,b6,b7,d9,d10,g3,g6,h2,h3,h6(type of investigation, investigation findings, component code,impact code, conclusion),h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the screen attempts to communicate with the execute board and fails in sequence after three attempts.Charters appear on the display.Spiral cable continuity was tested end to end; cable is ok.Replacement of the video generator board was recommended.The pim module is broken, likely due to impact are requires replacement as well.Additional parts and tests not performed because the device does not enable or enter service mode.Device was not released for use.The problem has not yet been resolved as we are waiting for the customer to purchase the parts quoted by the technician, the record will be updated when this information becomes available.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h3, h6 (health effect ¿ clinical code), h11.Corrected field - e1, e2, e3, e4, g2, h6(component codes).
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID - TYPE "N" PLUG
• 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: 22011120
• Report Number: 2249723-2025-0002188
• Device Sequence Number: 18113737
• Product Code: DSP
• UDI-Device Identifier: 10607567114187
• UDI-Public: (01)10607567114187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 03/23/2026
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 03/11/2026; 03/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown