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

Model Number	0998-00-0800-35
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restriction, event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cardiosave intra-aortic balloon pump (iabp) had upper display in a different color than normal.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d5, e2, e3, e4, g1(contact person ¿ mfg site), g2, g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d10, e1(event site name, event site city).Due to character limit in e1 (event site name: (b)(6) center 1 - health center).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that display and front stickers must be replaced.The repair has not been performed.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

• Brand Name: CARDIOSAVE HYBRID TYPE M 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: 21662657
• Report Number: 2249723-2025-0001353
• Device Sequence Number: 8431536
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: (01)10607567109107
• 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
• Report Date (Section B): 11/27/2025

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: Other
• Device Model Number: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 11/27/2025
• 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