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

Model Number	0998-00-0800-83
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, d10, g3, g6, h2, h6 (health effect clinical code), h11.
Additional Manufacturer Narrative
Another contact info: (b)(6).Updated fields: b4, g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions), h11.The nurse confirmed that all three pumps displayed a system over temperature alarm.After restarting, the pump was functioning normally.The nurse stated the balloon was placed axillary, and esp personnel provided the axillary placement disclaimer.The patient heart rate was in the 120s.Esp personnel confirmed the pumps were not positioned close to the bed and that airflow was not obstructed.Although the nurse reported nothing around the pump, esp personnel advised repositioning it to ensure ventilation.Esp personnel also recommended keeping another balloon pump available in case the alarm recurred.Product surveillance information was collected.Esp personnel also confirmed with cat lane that only one pump had previously been reported with a system over temperature alarm.
Additional Manufacturer Narrative
Due to character limit: e1- (event site name)- (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer via emergency support program line, that cardiosave intra-aortic balloon pump (iabp) had a system over temperature alarm.There were no patient harm or injury was reported.

• Brand Name: CARDIOSAVE RESCUE
• 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: 24034481
• Report Number: 2249723-2026-0000383
• Device Sequence Number: 18410718
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 03/22/2026; 04/10/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BALLOON; CARDIOSAVE (OTHER 2 PUMPS)
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 73 KG