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

Catalog Number 295025-001

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2015

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 # 3003761017-2015-00038) and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00039).The customer reported that the freedom onboard batteries caused "high temperature" fault alarms on the freedom driver while supporting a patient from mayo rochester.The patient replaced the onboard batteries and the alarm resolved.This alleged failure mode poses a low risk to patient because although the freedom onboard batteries caused "high temperature" fault alarms, it did not prevent the freedom driver from performing its life-sustaining functions.The freedom onboard batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdrs.

• Brand Name: FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq., vp reg affa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4488085
• MDR Text Key: 5500117
• Report Number: 3003761017-2015-00038
• 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: 01/20/2015

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: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 24 YR