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

Model Number	293001-001
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion external battery would not charge after 24 hours in a companion 2 driver.
Additional Manufacturer Narrative
The companion external battery was returned to syncardia for evaluation.Review of the system management (smbus) data revealed that the battery exhibited a safety over charge current (socc) permanent fault and its safety monitor had permanently disabled the input / output functions, confirming the customer-reported issues.The root cause for the device malfunction was determined to be that the battery was likely subjected to a deep discharge cycle with a prolonged duration prior to being recharged.When the battery was put into charge state, its safety circuitry disabled its output for exceeding firmware safety charge current limits.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.
Event or Problem Description
This companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion external battery would not charge after 24 hours in a companion 2 driver.

• Brand Name: SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
• Common Device Name: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6852803
• Report Number: 3003761017-2017-00163
• Device Sequence Number: 637002
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 09/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2017
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1