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

Model Number	0998-00-0800-83
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported by customer prior to use that cardiosave intra aortic balloon pump screen hinges are broken.There was no patient involvement and no injury reported.
Additional Manufacturer Narrative
Corrected fields: e1-initial reporter name.Updated fields: b4, d9, e1-event site email address, e2, e3, g1- contact person at mfg site, g3, g6, h2, h3, h6-type of investigation, investigation findings, investigation conclusion and h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, verified issue that customer reported.The display top and bottom bezel was replaced.Complete pm during the repair.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2.Corrected fields: h11.After further review, an emdr for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no emdr is necessary.Please cancel in your database.
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: 21891049
• Report Number: 2249723-2025-0001917
• Device Sequence Number: 3405442
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 07/25/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/24/2025; 07/28/2025
• 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: N/A.
• Patient Sex: Unknown