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

Model Number	0998-00-0800-83
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) experienced an autofill failure.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected fields: b5, h6 (health effect clinical code and health effect impact codes).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, powered unit on and confirmed no errors before checking logs.Logs showed a large number of autofill errors.Specifically, fill fail - flush fill timeout with arg 0x6.Zero checked all transducers except helium tank transducer by exposing to atmosphere.No issues.Performed quick leak checks and then all manifolds test.No issues found.Technician brought his catheter and assisted with testing.Autofill failure confirmed.No more test equipment on hand to resolve issue.Found unit compressor not running continuously.Unit starts out at max power and then stops running compressor.Replaced front end board.Compressor now runs continuously.Performed testing to ensure device properly reading signals.Performed calibration of unit to ensure proper regulator calibration.Passed.Performed all autofill testing.Passed.Brought back into normal mode and unit ran on system trainer.Ready for use.Returned to customer.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) experienced an autofill failure.No harm 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: 22182786
• Report Number: 2249723-2025-0002570
• Device Sequence Number: 8505973
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/20/2025

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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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