MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
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 after switching on the cs300 intra-aortic balloon pump (iabp) flat screen monitor constantly flickers.
Additional Manufacturer Narrative
Getinge representative reported that the device is irreparable due to a defective display.Due to a lack of spare parts as the device is at end of life, the device has been taken out of service.
Event or Problem Description
It was reported that during a routine checl after switching on the cs300 intra-aortic balloon pump (iabp) flat screen monitor constantly flickers.There was no patient involvement.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18163076
• Report Number: 2249723-2023-04937
• Device Sequence Number: 12593099
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278(21)SI148897-K8
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063525
• 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,Followup,Followup
• Report Date (Section B): 09/24/2024

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/15/2024; 09/24/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/08/2024; 01/16/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown