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

Model Number	0998-UC-3023-55
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) found problem suspected with power supply.Fse had rechecked it with another power supply.Fse replaced the fan of power supply and run the unit for few hours, found working okay.Unit returned to customer.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) unit shutdown unexpectedly.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, g1(contact person-mfg site), g3, g6, h2, h6 codes (investigation findings, conclusion, conclusion), h11.The following investigation failure analysis and testing dept.(fat) the failure analysis and testing dept.Received power supply with a reported unit failure of machine not operating on mains ac.The failure analysis and testing dept.Performed a visual inspection and found the power supply to be excessively dusty.The fat proceeded to check the two 10- amp fuses on the ac line in.Both 10- amp fuses were open indicating a shorting of one or more components within the power supply.Due to the blown fuses, and the risk it poses to the cs300 test fixture this complaint cannot be investigated any further.However, probable cause of the power supply not functioning, is the excessive amount of dust in the supply resulting in overheating, resulting in a component short.Retaining the supply in the fat dept.Per procedure.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INT'L
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20027373
• Report Number: 2249723-2024-03419
• Device Sequence Number: 17975737
• Product Code: DSP
• UDI-Device Identifier: 10607567108728
• UDI-Public: (01)10607567108728(21)SI156057C9
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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-3023-55
• Device Catalogue Number: 0998-UC-3023-55
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 05/08/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/25/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2009
• 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