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

Model Number	0998-00-3023-68
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit.E1 (initial reporter: (b)(6).A getinge field service engineer (fse) found that video rec to led cable was defective.Replaced this cable part number (0012-00-1747).Pm services completed.Full pm, safety, calibration, and functionality checks passed factory specifications.Returned to clinical service upon completion.
Event or Problem Description
It was reported by getinge field service technician, that during preventive maintenance check, the monitor of cs300 iabp (intra-aortic balloon pump) was flickering on and off.There was no patient involved.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21409146
• Report Number: 2249723-2025-0000764
• Device Sequence Number: 12841255
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 02/19/2025

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: 0998-00-3023-68
• Device Catalogue Number: 0998-00-3023-68
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/19/2025
• 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 AS NO PATIENT INVOLVED
• Patient Sex: Unknown