MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during regular inspection, the cs300 intra-aortic balloon pump (iabp) had a broken fiber connector panel.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
The fse that encoutered the issue replaced the damaged fiber connector panel.Three (3) gfe attempts have been performed to obtain additional information.No response has been provided, the complaint will be closed and in the event new information and/or device was to become available, the file will be reopened and updated.
Event or Problem Description
It was reported that during regular inspection performed by a getinge field service engineer (gfse), the cs300 intra-aortic balloon pump (iabp) had a broken fiber connector panel.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 17548769
• Report Number: 2249723-2023-03664
• Device Sequence Number: 12497636
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: 10607567108803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: Other
• Device Model Number: 0998-UC-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown