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	Overheating of Device (1437); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, d9, e1(event site address), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Getinge fse was dispatched to evaluate the unit.Fse replaced scroll compressor assembly.Performed all calibration and leak tests.Suitable to use.Ran the system overnight and the checked the temperature at the end, which only rose to 34 degrees (alarm is only activated when 80 degrees).Shipped the device back to the customer from the office.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- initial reporter- (b)(6).Additional event site telephone - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during reoutine check, cardiosave intra-aortic balloon pump (iabp) was overheated and switched off.There was no patient involvement.

• 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: 23863376
• Report Number: 2249723-2025-0005191
• Device Sequence Number: 21344207
• 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
• Report Date (Section B): 03/12/2026

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: 0998-00-0800-31
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/12/2026
• 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