MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

Catalog Number 293001-001

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a redundant, alternate power source of external wall power and additional external batteries.The companion external battery 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 customer, a syncardia authorized distributor, reported that the led lights on the external battery did not light up.

Manufacturer Narrative

The companion external battery was returned to syncardia for evaluation.Investigational testing confirmed the customer-reported issue that the companion external battery's gas gauge does not indicate the battery's smbus displayed relative state of charge when activated.The root cause for the inoperative gas gauge could not be conclusively determined, however, is likely due to an internal hardware failure.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.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the led lights on the external battery did not light up.

• Brand Name: SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• 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: 6408385
• MDR Text Key: 70305751
• Report Number: 3003761017-2017-00051
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Age: 55 YR