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

Model Number	0998-00-3013-58
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
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, the cs100 intra-aortic balloon pump (iabp) does not work.
Event or Problem Description
It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) unit does not work.There was no patient involvement.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the cs100 intra-aortic balloon pump (iabp) and observed a leak in the drive manifold.Also, the unit failed the fiber optic module tests.The fse replaced drive manifold and fiber optic module assembly.Unit passed all calibration, functional and safety tests performed.Equipment suitable for clinical use.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 17864237
• Report Number: 2249723-2023-04318
• Device Sequence Number: 20315765
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: (01)10607567107622(21)SA02557-D4
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031636
• 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,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: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 03/14/2024; 09/24/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/29/2023; 03/15/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown