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

Model Number	0998-00-0800-53
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) malfunctioned.No patient involved.No harm reported.Screen not working has been reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that unable to replicate reported issue.Both display test and touch screen test passed without issue multiple times.Product passed all functional and safety tests per manufacturer specifications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site name (b)(6) univ upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated field: b1, b4,d10, g3, g6, g7, h2, h6(type of investigation, investigation findings, investigation conclusions), h11 corrected fields: b6, b7, e2, g2 kindly revert a1(patient id) and h4 as it should be kept blank.A getinge field service engineer (fse) evaluated the unit, but was unable to replicate the reported malfunction.The touchscreen calibration passed on the first attempt.Both the display test and the touchscreen test passed without issues multiple times.There were no errors relating to either screen visible in the logs and there were no errors more recent than july 9th, none of which were related to the touch screen.The fse completed product inspection per customer or manufacturer requirements.Fault logs were provided, but there was no issue relevant to the reported malfunction.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 50928836
• Report Number: 2249723-2026-0004467
• Device Sequence Number: 10722257
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• 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.
• Patient Sex: Unknown