MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART

Catalog Number	P/N 397003-001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, touch screen on the hospital cart display does not respond appropriately.Multiple attempts at calibrating the screen were unsuccessful.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion hospital cart s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found scuff marks on the lcd rear housing.Visual inspection of internal components found no abnormalities.Hospital cart passed all areas of functional testing for acceptance at incoming inspection.Touchscreen was successfully calibrated prior to functional testing.An extended 48-hour observation run was performed in an attempt to replicate the reported issue.Touchscreen feedback stayed within calibration and was fully functional for the duration of the test run.Customer complaint was not replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated; the root cause of the reported calibration issues was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the event.Damage found on the lcd rear housing was cosmetic only and could not affect the functionality of the device.No evidence of a device malfunction was found.Hospital cart was not in patient use at time of complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
Event or Problem Description
Per hospital staff, touch screen on the hospital cart display does not respond appropriately.Multiple attempts at calibrating the screen were unsuccessful.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Common Device Name: HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 19236900
• Report Number: 3003761017-2024-00077
• Device Sequence Number: 12771258
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Catalogue Number: P/N 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown