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

Catalog Number 293001-001

Device Problems Failure to Charge (1085); Charging Problem (2892)

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

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion external battery was not supporting a patient.The customer reported that the companion external battery would not hold a charge when inserted in several backup companion 2 drivers.The customer reported that the companion external battery would not charge despite the battery being left in a plugged in companion 2 driver for over 24 hours.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not supporting a patient.In addition, it would 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.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

This companion external battery was not in patient use.The customer reported that the companion external battery would not hold a charge when inserted in several backup companion 2 drivers.The customer reported that the companion external battery would not charge despite the battery being left in a companion 2 driver connected to external wall power for over 24 hours.The external battery was returned to syncardia for evaluation.Visual inspection of the external battery revealed no anomalies.The external battery was connected to battery evaluation software.Review of the data revealed no permanent faults, but it was in a state of significant deep discharge and exhibited a "pack under voltage" status flag as a result of its over-discharged condition.The external battery was in a "zero voltage charge" recovery mode, which would cause the customer to perceive that it was not operating.The external battery was connected to a ground power source and was able to be fully charged.The external battery was then tested and passed all testing and performed as intended.The external battery was returned to service.The reported issue posed a low risk to a patient because the issue was observed when the companion external battery was not in patient use.In addition, it would not prevent a companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external wall power and an internal, emergency battery.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 EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• 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: 5374305
• MDR Text Key: 36636431
• Report Number: 3003761017-2016-00007
• 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
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• 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: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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