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

Model Number	0998-00-0800-52
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
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 routine check the cardiosave intra-aortic balloon pump (iabp) failed a leak test.Pim leak test failed.There was no patient involvement.No harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that confirmed patient interface module (pim) test result failed.Machine physical overview reported ok.The fse checked pim and found iab port was loose.Tightened it and performed pim test and result passed.The fse performed 30psi calibration.Machine functional checks passed and safety test passed.Product passed all functional and safety tests per manufacturer specifications.Device was returned to user and cleared for clinical use.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 50837171
• Report Number: 2249723-2026-0004379
• Device Sequence Number: 21341988
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• 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): Yes
• Date Device Manufactured: 02/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown