MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, 3.1 EDITION; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-65
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during inspection the cardiosave intra-aortic balloon pump (iabp) malfunctioned.The fiber connector section need adjusting.No patient involved and no harm is reported.
Additional Manufacturer Narrative
Event site namecheck spelling (b)(6) event site postal code: 2458575 upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, 3.1 EDITION
• 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: 50835211
• Report Number: 2249723-2026-0004368
• Device Sequence Number: 16018028
• Product Code: DSP
• UDI-Device Identifier: 10607567113432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown