MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, 3.1 EDITION; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-65
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
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 intra-aortic balloon (iab) optical sensor malfunction alarm.As a result, arterial pressure measurement via the optical sensor became unavailable.Patient ecg electrode became detached, resulting in loss of the ecg trigger source.The iabp automatically switched to internal trigger mode and therapy continued without interruption.Reconnecting the optical sensor connector multiple times did not resolve the alarm.Use of the optical sensor was discontinued and arterial pressure monitoring was switched to an external pressure input.After completion of the pci procedure, the patient was transferred to the icu and continues to receive iabp therapy under temporary pacing support.No injury reported.After reconnecting the optical sensor, there seemed to be no further problems, and the device-related concerns were resolved over the phone.The customer cancelled the visit.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site postal code: (b)(6).Event site telephone: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, 3.1 EDITION
• 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: 50785618
• Report Number: 2249723-2026-0004316
• Device Sequence Number: 18534487
• Product Code: DSP
• UDI-Device Identifier: 10607567113432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2022
• 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: Intra-Aortic Balloon TransRay Plus 40cc
• Patient Sex: Unknown