MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Premature Discharge of Battery (1057); Charging Problem (2892); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial (1 of 2).

Event Description

The reported issue involves two freedom onboard batteries and are reported under two separate medical device reports: (1) freedom onboard battery, s/n (b)(4) (mfr report # 3003761017-2016-00279) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00280).The customer reported that the freedom onboard batteries discharge too quickly.The customer also reported that the patient subsequently exchanged the freedom onboard batteries.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard battery s/n (b)(4) will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation a review of the freedom onboard battery's system management bus (smbus) data revealed no anomalous values and all communications were normal.Additionally, a charge and discharge test was performed and no anomalous behavior was observed.The freedom onboard battery performed as intended and there was no evidence of a device malfunction.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) follow-up report (1 of 2).

Event Description

The reported issue involves two freedom onboard batteries and are reported under two separate medical device reports: freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00279) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00280).The customer reported that the freedom onboard batteries discharge too quickly.The customer also reported that the patient subsequently exchanged the freedom onboard batteries.There was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5839939
• MDR Text Key: 52283685
• Report Number: 3003761017-2016-00279
• 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,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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: 56 YR