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

Model Number 397002-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver displayed an emergency battery red led, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver displayed an emergency battery red led but did not sound an alarm.The customer also reported that the patient was switched to a backup companion 2 driver.The original companion 2 driver was rechecked and appeared to be working properly and the patient was switched back to the driver.The customer also reported that after a couple of hours supporting the patient, the companion 2 driver again displayed an emergency battery red led but no alarm.The customer also reported that there was no adverse patient impact due to the driver exchanges.

Manufacturer Narrative

The emergency battery red led being displayed without an alarm as reported by the customer could only be reproduced during the initial boot up (first 120 seconds) of the driver.Per rd-139 syncardia system companion 2 driver system software requirements specification (srs 4273), all alarms shall be disabled for the first 120 seconds on boot.After full boot up the driver functioned as intended with no battery malfunctions observed.Investigation testing determined that the driver functioned as intended and passed all requirements.Additionally, the emergency battery was further tested independently and found to function as intended and met all specifications.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4)follow-up report 1.

• 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
• MDR Report Key: 7625154
• MDR Text Key: 111878674
• Report Number: 3003761017-2018-00232
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR