MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-58
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
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 cs300 intra-aortic balloon pump (iabp) has a black screen and does not work.
Event or Problem Description
It was reported that during a routine check by the user, the cs300 intra-aortic balloon pump (iabp) has a black screen and does not work.There was no patient involved.
Additional Manufacturer Narrative
A getinge field service engineer(fse) evaluated the unit, and replaced the display controller.The fse checked and verified the device, and determined that the equipment was then suitable for clinical use.The unit passed all functional and safety testing.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: d1, d4(model# & catalog#).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L
• 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: 18372688
• Report Number: 2249723-2023-05422
• Device Sequence Number: 20775035
• Product Code: DSP
• UDI-Device Identifier: 10607567108759
• UDI-Public: (01)10607567108759(21)SI115795A8
• 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,Followup,Followup
• Report Date (Section B): 10/02/2024

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-UC-3023-58
• Device Catalogue Number: 0998-UC-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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 01/10/2024; 02/26/2024; 10/02/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/11/2024; 02/27/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown