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 Codes	Image Display Error/Artifact (1304); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pah rp cardiosave screen not working on (b)(6) 2025 - customer advosed screen not working.No one was harmed.Cardiosave hybrid type i plug.Technicians remarks: |wd: 2023-01-01 |ct: prem cardiosave s/n: (b)(6) |so1d 2025-08-21 |so2d 2024-12-02 |so3d 2024-01-10.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Due to character limitation in e1 for event site telephone, the full event site telephone is (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: h6 (component codes).
Event or Problem Description
It was reported during routine testing that cardiosave iabp maintenance required alarm in the device.No patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) visited the site.Found device was showing "maintenance may required" and also safety disk was due for replacement.Clear all the log files.Replaced the safety disk as due for replacement.Performed the full testing and calibration as per specifications.Performed the electrical safety testing as per as3551 standard.Device was working within specifications.

• 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: 23692384
• Report Number: 2249723-2025-0004911
• Device Sequence Number: 10288664
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 01/04/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: H6 (COMPONENT CODES)
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown