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 Code	Insufficient Cooling (1130)
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 during use, the cardiosave intra-aortic balloon pump (iabp) had a ¿fan fault detected ¿ switch to another maquet iabp, if available, and contact maquet technical support¿ message.Patient was involved, no harm reported.The treatment was completed.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the fan located above the motor had an abnormal vibration.As the fans had been replaced in the field action, it was decided that both fans would be replaced with the new ones.After the replacement, the equipment cycled for more than 4 hours and did not present any further messages or any abnormalities in its operation.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Initial reporter: (b)(6).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 "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: 50882202
• Report Number: 2249723-2026-0004424
• Device Sequence Number: 15909396
• Product Code: DSP
• UDI-Device Identifier: 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,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown