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

Model Number	0998-00-0800-83
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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 rescue intra-aortic balloon pump (iabp) battery won¿t charge.
Additional Manufacturer Narrative
Updated fields - b4, d9, g1, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, health effect ¿ impact codes, investigation conclusion), h11.Corrected fields - b5.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse couldn¿t not duplicate/verify this.The battery pack was sent to the biomed shop without the instrument.The fse had access to see the battery.The battery led icons indicated that the battery was depleted.While onsite for pm the fse verified that all batteries were charged to 100%.The unit has one power supply adapter in slot #1 and a charged battery in slot #2.The unit did not any issues with charging the battery.Customer also confirmed that there was not an issue with the instrument.The issue according to the operator was just with the battery.The fse replaced the battery pack.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.Returned unit to service.
Event or Problem Description
It was reported that cardiosave rescue intra-aortic balloon pump (iabp) battery won¿t charge.There was no injury 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: 22041848
• Report Number: 2249723-2025-0002243
• Device Sequence Number: 9061581
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/01/2025

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: 05/05/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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