MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE, CHINESE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-75
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site name is hengyang central hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) during the inspection reported that automatic inflation was restricted.There was no personal injury.Patient not involved.
Event or Problem Description
After further review, safety disk was expired hence record need to cancel, no more malfunction no harm.An emdr (2249723-2025-0002721) for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel in your database.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.After further review, safety disk was expired hence record need to cancel, no more malfunction, no patient involved, no harm.An emdr (2249723-2025-0002721) for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel in your database.

• Brand Name: CARDIOSAVE RESCUE, CHINESE
• 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: 22326702
• Report Number: 2249723-2025-0002721
• Device Sequence Number: 9418633
• Product Code: DSP
• UDI-Device Identifier: 10607567112312
• UDI-Public: (01)10607567112312
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 0998-00-0800-75
• Device Catalogue Number: 0998-00-0800-75
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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