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

Catalog Number	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	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The companion hospital cart was not supporting a patient at the time of the event.The customer, a syncardia certified hospital, reported that the display on the companion hospital cart was "frozen", i.E., not recognizing touch.The hospital staff could not recalibrate the screen.
Additional Manufacturer Narrative
The companion hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion hospital cart s/n 50062 was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found no abnormalities.Hospital card failed functional testing for acceptance at incoming inspection for sections all related to inability to interact with the lcd screen, confirming reported complaint.Additional testing included replacing the lcd module due to inability to interact with the lcd screen.Hospital cart passed all areas of functional testing with replacement module, including ground continuity testing.Failure investigation for this complaint confirmed he reported issue at incoming inspection.The customer complaint was replicated during tersting; the root cause of the reported inability to interact with the lcd screen was determined to be a faulty lcd module.Failure investigation identified no other failures or damage that could have contributed to the reported complaint.The hospital cart was not supporting a patient 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
The companion hospital cart was not supporting a patient at the time of the event.The customer, a syncardia certified hospital, reported that the display on the companion hospital cart was "frozen", i.E., not recognizing touch.The hospital staff could not recalibrate the screen.

• 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15601296
• Report Number: 3003761017-2022-00106
• Device Sequence Number: 2263223
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/26/2024

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: 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: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2014
• 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