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

Model Number 397002-001

Device Problems Battery Problem (2885); Audible Prompt/Feedback Problem (4020)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver did not pass the system check procedure.

Manufacturer Narrative

The reported issue was confirmed by review of the patient data file which revealed a system check test failure for the 9-volt battery reading below acceptable limits (6.500 v - 10.000 v).The 9-volt battery is replaced at every service (90-days of use interval or 2-year calendar interval).The battery that was replaced at the most recent service interval had an expiration date of march 2021.At the time that the 9v battery failure occurred, the battery was not expired.It is suspected that the 9v battery experienced an unexpected cell depletion malfunction.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its investigation 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
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10503234
• MDR Text Key: 207528945
• Report Number: 3003761017-2020-00192
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2020
• 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