MAUDE Adverse Event Report: SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problem Failure to Calibrate (2440)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

The companion hospital cart will be returned to syncardia for evaluation.The results 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 while supporting a patient the companion hospital cart's touch screen did not calibrate.There was no reported adverse patient impact.

Manufacturer Narrative

The companion hospital cart passed all functional testing.Additionally, the hospital cart was tested using two known functioning companion 2 drivers in an attempt to confirm and replicate the customer-reported issue that the touch screen did not calibrate.The hospital cart passed all calibration tests.The root cause of the customer-reported issue could not be determined.The companion hospital cart performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5376 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CART
• MDR Report Key: 10705487
• MDR Text Key: 212340333
• Report Number: 3003761017-2020-00208
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 10/23/2020
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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: 52 YR