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

Model Number 295025-001

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom onboard battery was not supporting a patient.The customer, a syncardia certified hospital, reported that once the freedom onboard battery was inserted into a freedom driver, the driver annunciated an alarm.

Manufacturer Narrative

The freedom onboard battery was evaluated per the freedom onboard battery evaluation procedure and passed all sections.During investigation testing, there was no evidence of a device malfunction and the battery performed as intended.The freedom driver used at the time of the reported issue was not returned and therefore could not be included in this investigation.Per freedom driver system operator manual section 10, the battery alarm is indicated by a beeping tone in the range of 78 to 92 decibels and a blinking yellow visual alarm.This will occur if one or both batteries have less than 35% remaining charge, are removed, or are otherwise not functioning or recognized by the driver.The root cause of the customer-reported freedom driver alarm when the freedom onboard battery was inserted could not be conclusively determined.It is possible that the battery was below the 35% threshold when the customer attempted use it.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5685 (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12775521
• MDR Text Key: 281416953
• Report Number: 3003761017-2021-00210
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• 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
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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: Health Professional
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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