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

Catalog Number 397003-001

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer, a syncardia certified hospital, reported that the companion hospital cart screen had some display screen noise while supporting a patient.There was no reported adverse patient impact.

Manufacturer Narrative

During the investigation testing, the customer-reported issue of display screen noise could not be confirmed nor reproduced.The hospital cart passed incoming functional testing with no observed issues.Additional testing was then performed with the companion 2 driver that was docked in the hospital cart at the time of the reported issue.When this driver was switched from external air to compressors, no display screen noise was observed on the hospital cart.Additionally, the hospital cart was tested for a second time to include a 48-hour burn in to check for functionality.The cart passed testing again with no malfunctions occurring.The root cause of the customer-reported issue could not be determined.The hospital cart performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• MDR Report Key: 9842129
• MDR Text Key: 183978744
• Report Number: 3003761017-2020-00089
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR