MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-83
Medical Device Problem Codes	Gas/Air Leak (2946); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cardiosave intra-aortic balloon pump (iabp) had a helium leak.There was no harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d9 d10, e1(event site mail), g3, g6, h2, h3, h6 (problem code, investigation findings, component code, impact code), h11.Additional information- e1 (initial reporter) - (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the back handle on the cover was bend inwards and putting pressure on the brass check valve.The fse replaced both the cover, console and valve, 300 psi check.After repair the unit passes all tests and was returned for clinical use.
Event or Problem Description
It was reported that cardiosave intra aortic balloon pump (iabp) had a helium leak.No patient involved.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, investigation conclusions),h11.Despite good faith efforts (gfes), no further information has been provided.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

• Brand Name: CARDIOSAVE RESCUE
• 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: 23421551
• Report Number: 2249723-2025-0004475
• Device Sequence Number: 21295660
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 02/11/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/03/2025; 02/19/2026
• 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.; UNKNOWN.
• Patient Sex: Unknown