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

Model Number	0998-00-0800-83
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a issues with its battery holding a charge.There was no harm reported.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional infr initial reporter's name: (b)(6).
Additional Manufacturer Narrative
Updated field: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11 a getinge field service engineer (fse) evaluated the device.The fse replaced the two batteries the runtime on the new batteries could not be verified because they were new and not yet fully charged.The fse verified the runtime using a backup set of batteries and was unable to duplicate any charging or performance errors.Further communication was received from the fse vis email stating that the batteries that were reported not holding a charge were charged in full and had a proper two hour battery run time performed.The fse completed the repair successfully.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11 corrected field: h6- type of investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: h6(impact - codes).
Event or Problem Description
N/a.

• 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: 23287930
• Report Number: 2249723-2025-0004266
• Device Sequence Number: 12139179
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 09/25/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 01/01/2026; 03/05/2026; 03/06/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/01/2026; 01/01/2026; 03/06/2026; 03/06/2026
• 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: UNKNOWN.
• Patient Sex: Unknown