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	09/02/2026
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) did not display direct ecg input.Patient involved and no harm is reported.Unit was swapped and there was no impact on the patient or the treatment.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that they inspected the device but were unable to reproduce the problem.This time, the ecg cable (green connector) + minisim (simulation) did not receive a signal input.Fse connected the (letter) and performed testing, but they were unable to reproduce the symptoms.Fse also checked the signal input of the external input (moni-x cable), but there were no problems.Pumping operation via direct ecg input is ok.No abnormalities were found in the cardiosave or ecg cables this time.Device is now back in a condition suitable for clinical use.
Additional Manufacturer Narrative
Initial reporter: (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: 50864907
• Report Number: 2249723-2026-0004397
• Device Sequence Number: 9425317
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sex: Unknown