MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-62
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not accessible for testing due to the customer not requesting repair service.Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unexpectedly shutdown.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and noted that the reported issue per the log files was very intermittent and was not able to duplicate the issue.Due to the intermittent issue, the fse replaced the vent valve then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.The first name of the initial reporter in block e1 has been abbreviated due to field character limit; the full name should read (b)(6).
Event or Problem Description
N/a.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person), h4.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12032271
• Report Number: 2249723-2021-01308
• Device Sequence Number: 1631772
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112372
• 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): 03/10/2023

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: 0998-00-3023-62
• Device Catalogue Number: 0998-00-3023-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 03/10/2023
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 11/03/2021; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2010
• 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: UNKNOWN.
• Patient Sex: Prefer Not To Disclose