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

Model Number	0998-00-0800-75
Medical Device Problem Codes	Overheating of Device (1437); Pressure Problem (3012); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After further review, an initial emdr for this complaint was incorrectly submitted.The incident was determined to be a duplicate report to complaint (b)(4) (authority ref (b)(4).
Event or Problem Description
Na.
Additional Manufacturer Narrative
Due to character limitation (e1), (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during the use the cardiosave intra-aortic balloon pump (iabp) had the compressor is unable to provide normal pressure, with a maximum positive pressure not exceeding 400mmhg, resulting in severe performance degradation of the compressor.After installation, the performance does not meet the standards, there is abnormal noise from the accessories, and the pressure is insufficient.There was no harm reported.

• 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: 22607067
• Report Number: 2249723-2025-0003179
• Device Sequence Number: 13162690
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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: UNKNOWN.
• Patient Sex: Unknown