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

Catalog Number 293001-001

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

This companion external battery was not in use by a patient.The customer reported that the companion external battery had "damaged" housing.This alleged failure mode poses a low risk to a patient because the issue was observed when the battery was not in use by a patient.In addition, the reported issue would not prevent the driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of an internal emergency battery and external wall power.Syncardia will conduct an investigation, and the results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This companion external battery was not in use by a patient.The customer reported that the companion external battery had "damaged" housing.Companion external battery s/n (b)(4) was returned to syncardia for evaluation.Review of the incoming inspection records did not reveal any anomalies.Inspection of the unit confirmed the customer reported issue and found a portion of the housing missing on the side of the housing.Although the root cause for the housing is unknown, this is likely a result of the battery sustaining an impact event.Evaluation of the unit did not reveal any other abnormalities.The damage sustained by companion external battery s/n (b)(4) was not significant enough to prevent the battery from properly supplying the companion 2 driver with power.Risk to the patient as a result of the customer reported issue is low because the battery was not in patient use.Even with the observed issue, the companion 2 driver system would have continued to perform its life-sustaining functions because the companion 2 driver utilizes multiple power sources, including replaceable external batteries, an internal emergency battery, and external wall power.Companion external battery s/n (b)(4) will be taken out of service.This issue will continue to be monitored and trended through the customer experience process.Syncardia has completed its evaluation of this driver and is closing this file.

• Brand Name: COMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4380597
• MDR Text Key: 20977721
• Report Number: 3003761017-2014-00318
• Device Sequence Number: 1
• Product Code: LOZ
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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