MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-31
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (initial reporter: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during setup on patient, the cardiosave intra-aortic balloon pump (iabp) did not display the pressure waveform when using fibre optic or pressure transducer.However, no patient harm was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse was unable to duplicate the issue after full reset of the device.Completed with full calibration, functional testing and safety check to factory specifications.Returned to the customer and cleared for customer use.Unit passed all functional and safety tests and was returned to normal use.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 22898484
• Report Number: 2249723-2025-0003610
• Device Sequence Number: 5986566
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: (01)10607567109053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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