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

Model Number	295025-001
Medical Device Problem Codes	Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003761017-2021-00210
• Device Sequence Number: 17672088
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown