MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-64
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
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, during a maintenance plan the cs300 intra-aortic balloon pump (iabp) switch is a little hard and the counter-pulse does not start.There was no patient involvement reported.
Additional Manufacturer Narrative
Updated fields: b4, d9(device available for eval), (investigation type, investigation findings & investigation conclusions).A getinge field service engineer (fse) evaluated unit.The switch was a little hard and the counterpulse does not start.Dissassembled and cleaned with contactless cleaner.Reassembly ok.The switch no longer blocking and the counter-pulse starts normally.All functional and safety checks been performed to meet factory specifications.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Suspect device originally distributed as system cs100, upgraded to cs300 using conversion kit.Udi information provided for original model/catalog, as per product labeling.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 18355896
• Report Number: 2249723-2023-05341
• Device Sequence Number: 17748940
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: (01)10607567107509(21)SA06680F7
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 03/24/2024; 09/24/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/25/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2007
• 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