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

Catalog Number 397003-001

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

This syncardia companion hospital cart was not in patient use.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 team member reported that during calibration, the touch screen on companion hospital cart s/n (b)(4) failed to respond to the operator's touch.

Manufacturer Narrative

Companion hospital cart s/n (b)(4) was not returned to syncardia for evaluation of this complaint.Instead, it remained at the site and a second complaint for the same issue was reported on january 27, 2017.(mfr.3003761017-2017-00034) companion hospital cart s/n (b)(4) will be returned to syncardia for evaluation for the second complaint.The results of the investigation will be provided in mfr.3003761017-2017-00034.Syncardia has completed its evaluation of this complaint and is closing the file.(b)(4).

Event Description

This syncardia companion hospital cart was not in patient use.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 team member reported that during calibration, the touch screen on companion hospital cart s/n (b)(4) failed to respond to the operator's touch.

• 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 Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6112615
• MDR Text Key: 60861812
• Report Number: 3003761017-2016-00375
• Device Sequence Number: 1
• Product Code: LOZ
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

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: Biomedical Engineer
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• 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