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 Codes	Communication or Transmission Problem (2896); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the fse that during a preventive maintenance the cardiosave intra-aortic balloon pump (iabp) had a non-functional power switch.The device powers on after being plugged in.The machine was displaying an error code 139.There was no patient involved and no harm is reported.A getinge fse was dispatched to evaluate the unit.The fse reported that after power management board was replaced the error was resolved.Moreover, it was reported that the problem remained and due to the shortage of spare parts it has not been resolved and the equipment was reported to be unusable.The equipment has been delivered to the customer.
Additional Manufacturer Narrative
Event site name: (b)(6).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: 50814115
• Report Number: 2249723-2026-0004354
• Device Sequence Number: 18694721
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: Other
• 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: 08/30/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown