MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE D PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-33
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Another contact info: (b)(6).A getinge field service engineer (fse) inspected the unit and verified that all connections were secure and properly configured.All required functional, calibration, and safety tests were performed and found to be within specification.The unit was also evaluated using a trainer and balloon, with no issues identified.After the customer repeated the pressure zeroing procedure, the issue was resolved.The unit was confirmed to be functioning normally and was cleared for clinical use.
Event or Problem Description
It was reported before use that the cardiosave intra aortic balloon pump (iabp) displayed pressure zeroing issue.There is no information about patient involvement.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 25094155
• Report Number: 2249723-2026-0002541
• Device Sequence Number: 13259718
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: (01)10607567109008
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/06/2026
• 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
• Patient Sex: Unknown