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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use on patient the cardiosave intra-aortic balloon pump (iabp) was having gas loss leak alarm, causing iabp to stop.No harm was reported.Intra-aortic balloon (iab) fill was done by pressing iab refill and started again, issue then repeated.A getinge filed service engineer (fse) was dispatched to evaluate the unit.Fse confirmed gas loss alarms in logs.No other errors were noted.All manifold test were successfully performed, no leak detected on device.Fse ran device in clinical mode - unable to replicate gas loss alarm, after 45 minutes of running.Iab was inspected and had no sign of perforation.No blood was seen in helium line.Helium tank was not empty.All connections check and secure.Patient not tachycardic or febrile.
Additional Manufacturer Narrative
Patient height: 171 cm.Event site telephone: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50472848
• Report Number: 2249723-2026-0004014
• Device Sequence Number: 10323430
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 0998-00-0800-31
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: Sensation plus 50cc IAB (b)(4)
• Patient Sex: Unknown
• Patient Weight: 143 LB