MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID - TYPE "N" PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-36
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block 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 product specialist went to the client to give training with the cardiosave intra-aortic balloon pump (iabp) equipment and identified that it had an auto fill error.There was no patient involved.
Additional Manufacturer Narrative
A getinge field service engineer (fse) reported that they restarted the unit to troubleshoot and was unable to reproduce the issue.The trainer was used in another unit and found to have the same issue.The issue was related to the trainer.The unit passed all functional and safety tests and was returned to customer.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID - TYPE "N" PLUG
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20133842
• Report Number: 2249723-2024-03605
• Device Sequence Number: 20638427
• Product Code: DSP
• UDI-Device Identifier: 10607567114187
• UDI-Public: (01)10607567114187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown