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

Model Number	0998-00-0800-36
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed a battery maintenance required message.There was no harm reported.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed a battery maintenance required message.Further evaluation and service review identified that both batteries were overdue for maintenance, and a battery maintenance process was initiated.Additionally, the device screen exhibited intermittent display disturbance (¿snow¿), for which further service was planned.There were no patient involved.
Additional Manufacturer Narrative
Updated field: b4, b5, d9, d10, g3, g6, g7, h2, h3, h6, h11.(type of investigation, investigation findings, health effect ¿ impact codes, component codes, investigation conclusions).Correction: event site city.Additional initial rep name: (b)(6).A getinge field service engineer fse was dispatched to the site to evaluate the unit.As per the attached images, both batteries are past their battery maintenance deadlines.A battery maintenance process was initiated and should last approximately 1 day.After the process is complete, the customer is advised to report whether the message has disappeared.If the message persists, further service must be provided.As per the attached images, the equipment screen is displaying intermittent "snow." a further service will be scheduled to address the issue, as inspections cannot be performed due to the equipment being in battery maintenance.Our local representative reported that the equipment displayed an alarm indicating the need for battery maintenance.The customer was visited and the procedure was performed on the equipment.After the service was completed, the equipment was released for use and, since then, there have been no further complaints from the customer.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: CARDIOSAVE HYBRID - TYPE "N" 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: 23540474
• Report Number: 2249723-2025-0004682
• Device Sequence Number: 9284240
• Product Code: DSP
• UDI-Device Identifier: 10607567114187
• UDI-Public: (01)10607567114187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/12/2026

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 05/14/2026
• 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