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

Model Number	0998-00-0800-32
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 for event site telephone, the full event site telephone is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by getinge fse during a follow-up inspection after implementation of fsca 323 and fsca 329, a functional test on the cardiosave intra-aortic balloon pump (iabp) unit revealed a malfunction of the capacitive touchscreen.There was no patient involvement reported.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.It was reported that during the follow-up inspection after fscas 323 and 329 the cardiosave intra aortic balloon pump (iabp) touch screen was malfunctioning.There was no patient involvement and no adverse event reported.A getinge field service engineer (fse) stated that the calibration process could not be completed successfully.Multiple calibration attempts according to the service instructions were unsuccessful.The defective dashscreen has been successfully replaced.All necessary tests were performed, and no further issues were detected after the replacement.The new dashscreen was successfully calibrated, and all relevant fsca procedures were also completed.The customer is retaining the defective screen for on-site analysis and investigation.The job is now complete.From our perspective, the device is fully functional, and the cardiosave has been cleared for clinical use again.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d8, e1(event site telephone), h6 (medical device problem code, investigation findings, component codes and investigation conclusions).
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE J 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: 24320484
• Report Number: 2249723-2026-0001220
• Device Sequence Number: 21213255
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Model Number: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/24/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/11/2026; 03/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown