MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2015

Event Type  malfunction  

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 # 3003761017-2015-00049) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00050).The customer reported that the freedom onboard batteries were unable to hold a charge on the freedom driver while supporting a patient.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 although the freedom onboard batteries were unable to hold a charge, 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 batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in supplemental mdrs.

• Brand Name: FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq. ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4488075
• MDR Text Key: 21325891
• Report Number: 3003761017-2015-00050
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2012
• 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: 61 YR