MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA CMPANION EXTERNAL LI-BATTERY PACK

Model Number 293001-001

Device Problems Failure to Charge (1085); Disconnection (1171); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not supporting a patient.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

This companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver was disconnected from wall power while in the hospital laboratory.The customer also reported that the companion 2 driver was reconnected to wall power and after approximately one week, the companion external battery did not charge.

Manufacturer Narrative

Visual inspection of the battery revealed no anomalies.A review of the system management (smbus) data revealed no anomalies and initial functional testing revealed its input/output functions were operational.Additional testing and evaluation was performed and the external battery successfully passed all sections of the procedure, which includes charge testing.The battery performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA CMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7586817
• MDR Text Key: 111152471
• Report Number: 3003761017-2018-00230
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 293001-001
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• 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