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

Model Number	0998-00-0800-83
Medical Device Problem Codes	Inability to Auto-Fill (1044); 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 investigation.
Event or Problem Description
It was reported that the cardiosave intra aortic balloon pump (iabp) had helium not refilling.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11, d9.H3, h6 (type of investigation, investigation findings,investigation conclusions) 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, b5, b6, b7, d9, d10, e1 (initial reporter, event site telephone, event site mail), g3, g6, h2, h3, h6 (type of investigation, medical device ¿ problem code, investigation findings, component codes, investigation conclusions), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that this unit was only used for transport therefore there was no cart.Upon inspection the fse that the machines metal cover where the handle is at for lifting purposes in the back, was bent inwards and the screws were tearing through the sheet metal.This caused the handle to put pressure on the check valve, bending it and causing a leak.Therefore, the fse replaced the damaged cover and the check valve.The unit passed all tests and was returned to service.
Event or Problem Description
It was reported, the cardiosave intra-aortic balloon pump (iabp) had a helium leak when trying to fill with an external supply.There was no patient involvement reported.

• 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: 23423649
• Report Number: 2249723-2025-0004483
• Device Sequence Number: 8253120
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 0998-00-0800-83
• 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: 12/22/2025; 02/12/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/29/2025; 02/20/2026
• 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: N/A.; UNKNOWN.
• Patient Sex: Unknown