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

Model Number	0998-00-3023-61
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
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, the cs300 intra-aortic balloon pump (iabp) unit has a sensor module error.There was no known risks to patients.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.At this time, the customer has not requested for getinge to repair the unit for the reported malfunction.A supplemental report will be sent if additional information is received.H3 other text : not returned to manufacturer.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: 19351496
• Report Number: 2249723-2024-02051
• Device Sequence Number: 15231348
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278(21)SI153386B9
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: Health Professional
• Device Model Number: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 02/07/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/10/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown