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	Display Difficult to Read (1181); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).Updated fields: h11, h2, g6, h6, a3, a4, a2, a1, b5 upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during clinical use, the cardiosave intra-aortic balloon pump (iabp) battery was unable to charge and had a not clear display.Display screen has glitch (red color) on waveform display.Patient was involved.No harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that bay2 slot cannot perform battery charging process.Power management board was re-seated and issue remain same.Full charged battery was returned back.Power management board was replaced the next day and bay2 was able to charge battery.Restarted machine 3 times and display working ok, no glitch issue happened on display screen.Performed display test and result passed.Performed machine simulation for 2 hours and display screen working ok.End user has to monitor the issue for four weeks.Product passed all functional and safety tests per manufacturer specifications.

• 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: 50393952
• Report Number: 2249723-2026-0003942
• Device Sequence Number: 21172741
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: (01)10607567108438
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/23/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 136 LB