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

Model Number	0998-00-3023-58
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
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 during a routine check, prior to use, the screen on the cs300 intra-aortic balloon pump (iabp) unit is broken.There was no patient involvement.
Additional Manufacturer Narrative
Updated data: b4, e1 (initial reporter and email), e2, e3,g2, g3, g6, h2, h10.
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.
Additional Manufacturer Narrative
Updated fields: b4, d9, e1 (event site postal code - (b)(6)), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11.Corrected fields: d5, e2, e3, g2.A getinge field service engineer (fse) evaluated the unit and states that fse resolved the issue clean and replace the screen connection.Fse then tested the safety and functionality as per factory specifications and iabp was then returned to customer for clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 19679768
• Report Number: 2249723-2024-02732
• Device Sequence Number: 12471584
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: (01)10607567108339(21)SI01458-F7
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2025

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 07/19/2024; 02/17/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/11/2024; 07/20/2024; 02/18/2025
• 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
• Patient Sex: Unknown