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

Model Number	0998-UC-3023-53
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated feilds: b4, d9, g3, g6, h2, h3, h6, (type of investigation, investigation findings, component codes, investigation conclusions), h11 a getinge field service engineer (fse) evaluated the unit and replaced batteries.The unit passed all functional and safety tests and was returned to customer.Root cause evaluation for the replaced part cannot be performed since the defective part was not returned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Additional information: event site contact person details: (b)(6) engineer.
Event or Problem Description
It was reported that during preventative maintenance, cs300 intra-aortic balloon pump (iabp) battery run failed at 64 minutes of the 135 minute run time test.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: 20840502
• Report Number: 2249723-2024-0004910
• Device Sequence Number: 20842946
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: (01)10607567108704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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