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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 No Display/Image (1183); Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver did not turn off when the key was switched to the off position.The customer reported that the lcd monitor was blank and the driver continued to pump for approximately 2 minutes before it turned off.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver did not turn off when the key was switched to the off position.The customer reported that the lcd monitor was blank and the driver continued to pump for approximately two minutes before it turned off.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the exterior and interior components revealed no anomalies.Review of the electronic patient data file revealed that the driver was turned on and then quickly received a shutdown command on the day of the reported issue.During the investigation, the driver was tested, and the key switch functioned as intended during performance testing.The reported issue could only be duplicated by intentional "jostling" of the key switch when the driver was operating on a depleted internal emergency battery without connection to an external power source.Testing demonstrated that it took very little movement of the key switch towards the "on" position to initiate the startup sequence.When the startup sequence is initiated, the driver will continue to boot up regardless of whether the key is turned to the "off" position.However, returning the key to the "off" position initiates a shutdown sequence, which will continue after the driver completes full boot-up.The driver fully shut down once these two commands were fully processed.The investigation concluded that the companion 2 driver performed as intended, and there was no evidence of a device malfunction.The companion 2 driver was serviced and passed all final performance testing.The reported issue posed a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.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 Key5763870
MDR Text Key49402999
Report Number3003761017-2016-00251
Device Sequence Number1
Product Code LOZ
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 06/22/2016
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 Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2016
Initial Date FDA Received06/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2012
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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