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

Model Number	0998-00-3023-58
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
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 cs300 intra-aortic balloon pump (iabp) entrance for connecting the counterpulsation balloon catheter is broken.
Event or Problem Description
It was reported that during the transfer of the equipment, the cs300 intra-aortic balloon pump (iabp) entrance for connecting the counterpulsation balloon catheter is broken.
Additional Manufacturer Narrative
Corrected data: b5, d4(udi).Updated data: b4, g3, g6, h2, h10, h11.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit and the safety disk (0997-00-0985-05), and crm assembly (0997-00-0986-05) were replaced due to a blow during transport of the equipment.Functional and safety tests performed.

• Brand Name: CS300 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
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19928384
• Report Number: 2249723-2024-03199
• Device Sequence Number: 2797851
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: (01)10607567108339(21)SI01052-L6
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/04/2024

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 10/03/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/04/2024
• Date Device Manufactured: 03/08/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown