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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Failure to Sense (1559); Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 03/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
This companion 2 driver was not supporting a patient at the time of the reported issue.The customer reported that the companion 2 driver would not recognize external batteries.The customer also reported that multiple external batteries were inserted in the driver but the driver would not recognize the external batteries.This alleged failure mode poses a low risk to a patient because the driver was not supporting a patient at the time of the reported issue.In addition, it would not prevent the driver from performing its life-sustaining functions.The companion 2 driver has a redundant power source of external wall power.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
This companion 2 driver was not supporting a patient at the time of the reported issue.The customer reported that the companion 2 driver would not recognize external batteries.The customer also reported that multiple external batteries were inserted in the driver but the driver would not recognize the external batteries.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.The patient file was copied and reviewed, which revealed multiple external battery error alarms on the date of the customer experience ((b)(6) 2016).During investigation testing, the customer-reported issue could not be reproduced.Multiple external batteries were tested, and the driver recognized all of the external batteries and functioned as intended.Depleted external batteries would still be recognized by the companion 2 driver, and it is likely that there was an issue with the customer's external batteries.During investigation testing, there was no evidence of a device malfunction, and the driver met all test performance requirements.The companion 2 driver was not supporting a patient at the time of the customer-reported issue and, therefore, there was no patient impact.If the driver had been supporting a patient, the customer-reported issue would pose a low risk to a patient because the driver would have continued to perform its life-sustaining functions.The companion 2 driver is designed to always be connected to two power sources - the internal emergency battery and either of the two external batteries and/or an external ac power source.The driver was serviced before being released to finished goods.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.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
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 Key5564289
MDR Text Key42960616
Report Number3003761017-2016-00116
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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