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

Model Number	0998-00-0800-33
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine check by the customer the cardiosave intra-aortic balloon pump (iabp) malfunctioned.The mains indication light not glowing.No patient involved.There was no patient harm reported.The getinge field service engineer (fse) was dispatched to evaluate the unit.It was reported that main power indication assembly need to be replaced.No fault logs available.Fse stated that power cord and ac mains is working correctly and that only light is not working properly.
Additional Manufacturer Narrative
E.Initial reporter 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 D 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: 50767912
• Report Number: 2249723-2026-0004284
• Device Sequence Number: 18571248
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/15/2026

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: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown