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 Codes	Mechanical Problem (1384); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Due to character limitation in e1: (b)(6).
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) unit displayed a message that iabp may need maintainance.There was no harm or injury reported.
Event or Problem Description
It was reported that during routine check the cardiosave intra aortic balloon pump (iabp) displayed a bbia may need maintenance.There was no patient involvement and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d8, d9, d10, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, health effect impact codes and investigation conclusions), h11.Corrected field: h6 (medical device problem code).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, the equipment was checked, and it was displaying the following message "bbia may need maintenance." the error logs were checked for details on the message in question.The equipment displayed error #37 fill fail - shuttle purge timeout in the logs, so several verification tests were performed.During the functionality tests, it did not displayed any error, but for safety, atmospheric calibration was performed again.The equipment was under testing for approximately 2 hours, while during this period it did not display the error message again and there were no failures.The equipment is compliant and released for use.

• 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: 22492564
• Report Number: 2249723-2025-0002997
• Device Sequence Number: 7940288
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/08/2025
• 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