MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID TYPE D PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-33
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b6, b7, d9, d10, g3, g6, g7, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11 corrected fields: d5, e1 (initial reporter, event site email), e2, e3, e4, g2, h6 (component codes) due to character limitation in block e1: initial reporter: (b)(6).Reverted the contents of section h4 (manufacture date) to blank in mfg report number: 2249723 2026 0003587 it was received through good faith efforts (gfes) that the customer has refused to issue a purchase order (po) for any kind of evaluation/repair.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 50017575
• Report Number: 2249723-2026-0003587
• Device Sequence Number: 13154939
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• 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: 07/04/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown