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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 Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a malfunction alarm, 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 evaluation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a system malfunction alarm.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.During investigation testing, the system malfunction alarm was reproduced.Analysis of data collected from the pressure sensor printed circuit assembly (pca) confirmed a malfunction of the pressure transducer at m7 on the pressure sensor pca.This malfunction caused the driver to perceive an internal filter block and the system malfunction alarm was triggered.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).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a system malfunction alarm.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 Key6186808
MDR Text Key63092779
Report Number3003761017-2016-00406
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2015
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 Age40 YR
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