MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-65
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during start up, the cs100 intra-aortic balloon pump (iabp) units screen s black.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Event site postal code and state : (b)(6).It was reported that during the cs100 intra-aortic balloon pump (iabp) defective screen display.A getinge field service engineer (fse) report of screen display failure occurrence date unknown.The screen is distorted when the power is turned on.# 6/9 when the engineer checked, there was a similar symptom (the screen turned white).Tap the back of the monitor to improve the display.The video receiver board (d670-00-0736) and flat cable were replaced (d012-00-1429), and it was returned after confirming that it started normally.The device has been delivered to the customer and is ready for clinical use.There was no patient involvement.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The fat performed a visual inspection and found the parts to be in good condition.The fat installed pn 0670-00-0736 into cs300 test fixture serial number (b)(6) and tested the part to factory specifications per procedure number (b)(6) revision e and the cs300 service manual part number 0070-00-0689 rev w.No issue found.Installed pn 0012-00-1429 into cs300 test fixture serial number (b)(6) and tested the part to factory specifications per procedure number (b)(4) revision e and the cs300 service manual part number 0070-00-0689 rev w.No issue found.Fat could not verify the reported failure for any of these parts.Retaining the parts in the failure analysis and testing department per procedure number (b)(4) rev.Ap.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• 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: 17170533
• Report Number: 2249723-2023-02874
• Device Sequence Number: 17785681
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: 10607567108674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• 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): 04/03/2024

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-UC-3013-65
• Device Catalogue Number: 0998-UC-3013-65
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 03/11/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/18/2023; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown