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

Catalog Number 397003-001

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2023

Event Type  malfunction  

Event Description

The customer, a certified syncardia hospital, reported that there was difficulty in getting touch screen to recognize touch, that the screen would not calibrate, and when driver was removed from the hospital cart, the driver's screen functioned as intended.

Manufacturer Narrative

The companion hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 hospital cart s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external and internal components found no abnormalities.Hospital cart passed all areas of functional testing for acceptance at incoming inspection.Additional testing included installing a c2 driver to hospital cart.No malfunctions or issues with feedback or calibration occurred.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated during testing; root cause of the reported calibration and feedback issues with hospital cart.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a device malfunction found.Device 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 Description

The customer, a certified syncardia hospital, reported that there was difficulty in getting touch screen to recognize touch, that the screen would not calibrate, and when driver was removed from the hospital cart, the driver's screen functioned as intended.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: 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: 16273443
• MDR Text Key: 308503142
• Report Number: 3003761017-2023-00009
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male