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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, the hospital cart screen turned pink, when bottom left corner of the screen was bumped it would flash and glitch.Touch screen was not working.No adverse impact to patient reported.
Additional Manufacturer Narrative
Device history record (dhr) 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 damage on the front swivel skin.Visual inspection of the internal components found a crack in the neck weld, a pem nut pulled out of the front swivel skin, and a pem nut pulled out on the display skin.Hospital cart passed all functional testing for acceptance at incoming inspection.Additional testing included a "bump" test to replicate the bump described in the original complaint.While driver installed and running, display was manipulated by rotating and repeatedly "bumping" areas of the display.No issues or disruption in screen performance were found.An inspection of the display and cabling was also performed.No abnormalities were found.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 issue could not be determined.Failure investigation identified no test failures or damage that could have contributed to this complaint.Damage found to the neck weldment and display and swivel skins was cosmetic only.While evidentiary of impact shock, no damage to the display or cabling was found, therefore the found damage would not affect the functionality of the display.No evidence of a device malfunction was found and the device functioned as intended.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, the hospital cart screen turned pink, when bottom left corner of the screen was bumped it would flash and glitch.Touch screen was not working.No adverse impact to patient reported.

• 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 22743913
• Report Number: 3003761017-2025-00127
• Device Sequence Number: 8385961
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/21/2026

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): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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 Age: 42 YR
• Patient Sex: Male