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

Model Number	0998-00-0800-45
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-use inspection, the cardiosave intra-aortic balloon pump (iabp) power-on alarm electrical test 14.There was no information about patient involvement.No harm was reported.The customer replaced it with another device.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the equipment malfunctioned, displayed an error message upon startup, and could not start normally.After repair and testing, it was found to be working properly for customer use.Product passed all functional and safety tests per manufacturer specifications.
Event or Problem Description
It was reported by customer that during pre-use inspection, the cardiosave intra-aortic balloon pump (iabp) power-on alarm electrical test 14.There was no patient involvement.And no harm was reported.The customer replaced it with another device.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the equipment malfunctioned, displayed an error message upon startup, and could not start normally.After repair and testing, it was found to be working properly for customer use.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Even site name: (b)(6).Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
E1: event site telephone: (b)(6).Updated fields: h2, h11, b5, g6, g3, e2, d5, e3, h6 (health effect).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 50729893
• Report Number: 2249723-2026-0004254
• Device Sequence Number: 18788278
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: (01)10607567108421
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/11/2026

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
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown