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

Model Number	0998-00-0800-32
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cardiosave hybrid type j plug intra-aortic balloon pump (iabp) alarming battery maintenance even though battery were replaced, during use.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6) hospital.Event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
(b)(6).Updated field: b4, b5, b6, b7, d10, g3, g6, h2, h6 (type of investigation, investigation findings, health effect ¿ impact codes, investigation conclusions), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that, the error log was reset to remove the maintenance message.The batteries passed all tests and the equipment was released for use.The battery tests were completed successfully and the equipment did not present any new errors after verification.The equipment was deemed functional and released for use.
Event or Problem Description
It was reported by the customer that the cardiosave hybrid j type plug intra-aortic balloon pump (iabp) alarming battery maintenance even though battery were replaced.There was no patient involved.

• Brand Name: CARDIOSAVE HYBRID TYPE J 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: 23847392
• Report Number: 2249723-2025-0005170
• Device Sequence Number: 9571928
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• 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): 03/25/2026

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown