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	Failure to Run on Battery (1466)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
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) has a battery malfunction the unit switches off when unplugged from the mains.
Additional Manufacturer Narrative
Updated data: b4,e1(name),e2,e3,g3,g6,h2,h10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was not able to reproduce the reported issue.The console is operating normally.Reviewed with the site technicians, normal functional check on mains and on batteries.Disconnection and reconnection to the mains, no modification, normal operation of the console.Functional check on batteries 20 minutes, without a problem.Return to service of the console, with agreement from biomedical.

• 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: 16667625
• Report Number: 2249723-2023-01749
• Device Sequence Number: 20487145
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/21/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 11/20/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/02/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown