MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, TYPE B PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-53
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - event site name: (b)(6).Based on the evaluation results, the initially reported unspecified alarm cannot be confirmed due to the vague description.It is possible that it was the sudden shutdown alarm.The effect of unexpected shutdown analyzed by the fse is confirmed.The issue was resolved by transducer calibration following repeated condensation removal procedures.No parts were replaced.The most likely cause of the failure is 30 psi transducer calibration drift, possibly due to condensation.No escalation is required at this time.The issue continues to be monitored within the manufacturer¿s quality system.
Event or Problem Description
It was reported by the customer that before use, the cardiosave intra-aortic balloon pump (iabp) (b)(6) ¿kept beeping all the time¿.No patient was involved.The customer contact person was unable to provide any more information regarding patient/user harm or the discovery of this issue.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse identified significant system failures in the device logs: fault # 124 (pneumatics generated system failure - prolonged shuttle prs system failure) and fault # 58 system failure - shutdown.Based on the fse's assessment, these errors occurred due to pressure being applied to the shuttle transducer when the shuttle should be open to atmosphere (have zero gauge pressure).But both vacuum and shuttle transducers were at 27mmhg gauge at atmospheric pressure.Condensation removal procedure (crp) was performed, which caused a small change.The fse attempted 30 psi transducer calibration, but it was not possible.The fse performed multiple crps again.The transducers were then at 16 mmhg.The pim leak test and all manifolds test passed.The fse attempted 30 psi transducer calibration again, and this time it was successful.All transducers were at 0 mmhg gauge when open to atmosphere.No parts were replaced.The unit passed all functional and safety tests to manufacturer specifications.The device was returned to the customer ready for use.No parts to be replaced or returned.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 50929508
• Report Number: 2249723-2026-0004471
• Device Sequence Number: 10759685
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 09/29/2026

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown