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

Catalog Number 295025-001

Device Problem Battery Problem (2885)

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

Event Date 09/01/2022

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.

Event Description

The freedom onboard battery was not supporting a patient at the time of the event.The customer, a (b)(6) hospital, report that the freedom onboard battery did not hold a charge.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom onboard battery s/n (b)(6) was evaluated and passed all initial testing prior to being released to finished goods.Battery data review found no failures.Data could only be retrieved by connecting battery to a power supply, indicating negative communication,however.Visual inspection found no abnormalities.Battery failed functional testing; negative communication observed and gas gauge leds would not illuminate when button pressed.Additional testing was performed to test battery charge and ability to power driver.Battery failed to charge and was unable to power driver, confirming customer complaint.Failure investigation for this complaint confirmed the reported issue, the battery does not hold a charge and is unable to power driver.The complaint was replicated during testing; the root cause was determined to be a device malfunction as the battery became permanently disabled.Freedom onboard batteries incorporate a safety feature to disable functionality when the battery is compromised.Patient was not using the battery at the time so there was no reported adverse impact or risk to the patient.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.

Event Description

The freedom onboard battery was not supporting a patient at the time of the event.The customer, a (b)(6) hospital, report that the freedom onboard battery did not hold a charge.

• 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5204541234
• MDR Report Key: 15375092
• MDR Text Key: 299789684
• Report Number: 3003761017-2022-00100
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• 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