MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID - TYPE "N" PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-36
Medical Device Problem Codes	Failure to Power Up (1476); Battery Problem (2885); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Due to characterization limit e1 event site address line - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that during use the cardiosave intra-aortic balloon pump(iabp) equipment shut down unexpectedly, draining the battery and not powering on when the on/off button was pressed, even though it was connected to the electrical outlet.The event occurred while the equipment was in clinical use and directly impacted the conduction of the procedure, posing a risk to the patient's life, making it necessary for the care team to take immediate action.The patient died.
Additional Manufacturer Narrative
Updated fields - a3a, b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) evaluated the unit for the reported malfunction.A low battery alarm was observed in the logs.Tests were completed including battery tests and the unit was okay.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID - TYPE "N" 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: 24233885
• Report Number: 2249723-2026-0001038
• Device Sequence Number: 10338475
• Product Code: DSP
• UDI-Device Identifier: 10607567114187
• UDI-Public: (01)10607567114187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR
• Patient Sex: Female