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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 Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited a "single compressor malfunction" alarm while supporting a patient.The customer also reported that the "single compressor malfunction" alarm occurred after the driver was unplugged from external wall air and could not be resolved.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 "single compressor 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.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.Review of the electronic patient data file revealed one "single compressor malfunction" alarm, which confirmed the reported issue.During investigation testing, the "single compressor malfunction" alarm was reproduced.The root cause was a malfunction of the right compressor, which was running as the primary compressor at the time of the alarm.The right compressor was replaced.After replacement, the driver was retested and no alarms occurred.The driver met all test performance requirements.This failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a primary compressor and a redundant, secondary compressor, and the ability to connect to an external air source.In the event of a primary compressor malfunction, the companion 2 driver switches to operation on the secondary compressor.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 reported that the companion 2 driver exhibited a "single compressor malfunction" alarm while supporting a patient.The customer also reported that the "single compressor malfunction" alarm occurred after the driver was unplugged from external wall air and could not be resolved.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 Key5642636
MDR Text Key46169513
Report Number3003761017-2016-00192
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2016
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 Manufacturer05/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2016
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
Patient Age39 YR
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