MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INT'L; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-55
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse checked the system performance on a iabp trainer and balloon.The unit kept pumping for an hour and there were no issues found.The system is working to satisfactory.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a distorted ecg / pressure signal.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
Event or Problem Description
It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) had a distorted ecg / pressure signal.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h4, h10.Corrected fields: d1, d4, h6 (type of investigation, investigation findings, investigation conclusions).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INT'L
• 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: 13955984
• Report Number: 2249723-2022-00696
• Device Sequence Number: 4186512
• Product Code: DSP
• UDI-Device Identifier: 10607567108728
• UDI-Public: 10607567108728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/28/2023

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-UC-3023-55
• Device Catalogue Number: 0998-UC-3023-55
• Device Lot Number: N/A
• 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: 03/06/2022
• Supplement Date Received by Manufacturer: 03/06/2023; 07/28/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 03/08/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2011
• 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: N/A.; N/A.
• Patient Sex: Unknown