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	Calibration Problem (2890); Output below Specifications (3004); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cph rp cardiosave power up test failed, 11.11.2025; cardiosave power up test failed.No one was harmed.We are waiting for the customer to approve the quote to go onsite.Once the quote is approved and the fse goes onsite, more information can be requested by the relevant fse cardiosave hybrid type i plug technicians remarks: wd: 2019-11-01, ct: null, so1d 2025-10-02, so2d 2024-11-07.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (medical device ¿ problem code).
Event or Problem Description
It was reported by the customer that the cardiosave intra-aortic balloon pump(iabp) power up test failed and unable to have a calibrated touchscreen.There was no patient involved.
Additional Manufacturer Narrative
Other contact phone number:(b)(6).Updated field: b1, b4, b5, b6.B7, d8, d9, d10, g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected field h6 medical device problem code, health impact code.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the fault log not available, exact error code of power-up test that failed was not recorded by fse.During investigation it was noticed that the touchscreen was unable to be calibrated.The device was shipped to the workshop where they performed electrical safety testing, calibration checks and adjustments.The display monitor to video generator board kit was replaced.The device passed all safety and functional tests before being returned for normal use.

• 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: 23692758
• Report Number: 2249723-2025-0004912
• Device Sequence Number: 13042425
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 03/20/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/02/2026; 03/20/2026
• 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: UNKNOWN.
• Patient Sex: Unknown