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

Model Number	0998-00-3023-83
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit is not functional.It is unknown under which circumstances the event occurred or if there was any patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Getinge field service engineer (fse) confirmed reported issue.Display would not work.Replaced the video monitor panel (0160-00-0113) and video cable (0012-00-1747).Verified unit calibrated and passes all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
Event or Problem Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit is not functional.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 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: 15175165
• Report Number: 2249723-2022-01954
• Device Sequence Number: 6269955
• Product Code: DSP
• UDI-Device Identifier: 10607567108285
• UDI-Public: 10607567108285
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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: 0998-00-3023-83
• Device Catalogue Number: 0998-00-3023-83
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 02/12/2024; 02/12/2024
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 03/11/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2007
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown