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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problem Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the companion 2 driver made a clicking/slapping noise when it was unplugged from wall power while supporting a patient.The customer also reported that the noise continued when the driver was plugged back into the wall power.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a clicking/slapping noise, the companion 2 driver continued to perform its life-sustaining functions.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
The companion 2 driver was returned to syncardia for evaluation.During investigation testing, the unusual (clicking, slapping) noise could not be reproduced.However, a cable tie on one of the wire bundles was very close to the right cooling fan.It is possible that the cable tie made intermittent contact with the fan blades and caused the "clicking/slapping" sound observed by the customer.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 Description
The customer reported that the companion 2 driver made a clicking/slapping noise when it was unplugged from wall power while supporting a patient.The customer also reported that the noise continued when the driver was plugged back into the wall power.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
Manufacturer Narrative
Corrected data - patient information has been corrected to (b)(6), respectively.(b)(4) follow-up report 2.
 
Event Description
The customer reported that the companion 2 driver made a clicking/slapping noise when it was unplugged from wall power while supporting a patient.The customer also reported that the noise continued when the driver was plugged back into the wall power.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5905332
MDR Text Key54044741
Report Number3003761017-2016-00296
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
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 08/12/2016
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 Manufacturer11/30/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2016
Initial Date FDA Received08/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/17/2017
01/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age65 YR
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