MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397003-001

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2015

Event Type  malfunction  

Event Description

The companion hospital cart was not in patient use.The customer reported that the companion hospital care monitor is loose.This alleged failure mode poses a low risk to a patient because the issue was observed when the hospital cart was not in use by a patient.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The companion hospital care will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The companion hospital cart was not in patient use.The customer reported that the companion hospital cart monitor is loose.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 phase.The companion hospital cart was returned to syncardia for evaluation.Visual inspection of the exterior and interior of the hospital cart revealed that the display neck bracket was bent and the display hinge was loose.In addition, the two screws that secured the display hinge to the display neck bracket had fallen out.This was the root cause of the reported "wobbly screen." the reason the neck bracket was bent and the screws became dislodged could not be determined during the investigation.The display bracket and screws were replaced and the hospital cart passed all final performance testing.This failure mode posed a low risk to a patient because the hospital cart was not in patient use at the time the issue was observed.In addition, it would not prevent a docked companion 2 driver from performing its life-sustaining functions.The hospital cart, including the display screen, functioned as intended before and after replacement of the display neck bracket and screws.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.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4953260
• MDR Text Key: 22995636
• Report Number: 3003761017-2015-00236
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/15/2015

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: Other Health Care Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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