MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problem Battery Problem (2885)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the emergency battery low alarm came on while performing a system check.The device was not supporting a patient.

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported that the emergency battery low alarm came on while performing a system check.The device was not supporting a patient.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found multiple low battery alarms.Visual inspection of external components found no abnormalities.Visual inspection of internal components found capacitor damage not related to customer complaint.Functional testing at incoming inspection could not be performed due to depleted emergency battery.Test attempted after charging battery over 24 hours but was still unsuccessful.Battery tested separately, two alarms resulted due to low voltage.No permanent alarms observed.Additional testing determined battery unable to be charged appropriately, confirming customer complaint.Failure investigation for this complaint confirmed the reported issue.The complaint was replicated during testing; the root cause of the emergency battery low alarm was a battery failure.Failure investigation identified internal damage but was unrelated to the complaint.Companion 2 driver functioned as designed.Driver was not in use by a patient at time of customer complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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 ; 5205451234
• MDR Report Key: 16099685
• MDR Text Key: 306813160
• Report Number: 3003761017-2022-00147
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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