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

Catalog Number	397003-001
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The companion hospital cart will be evaluated and the results will be provided in a follow-up mdr.
Event or Problem Description
During routine evaluation, a syncardia technician reported that the companion hospital cart power cord icon did not appear on the screen as designed.
Event or Problem Description
During routine evaluation, a syncardia technician reported that the companion hospital cart power cord icon did not appear on the screen as designed.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion hospital cart was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found two scuff marks on the front skin, indicative of normal wear and tear.Hospital cart passed all functional testing and the reported display issue could not be replicated.Voltage dropping at the docking connector is a known issue that is currently being addressed, however, voltage for this device was measured through five power cycles without dropping during investigation.Failure investigation for this complaint confirmed the reported issue through experience with similar, prior incidents.The customer complaint was not replicated; the root cause of the reported display issue and potential voltage drop was determined to be a nonconforming power control board.Failure investigation identified no test failures or damage that could have contributed to the complaint.Scuff marks found on the front skin do not affect the functionality of the device.Device was not in patient use at the time of the 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.

• 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: 14757063
• Report Number: 3003761017-2022-00057
• Device Sequence Number: 12288920
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: Other
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2012
• 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