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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 Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited a fault alarm while supporting a patient at the hospital (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The customer also reported that after the companion 2 driver was returned to the distributor, the driver did not pass the system check.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a fault alarm, it did not prevent the driver from performing 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
(b)(4) follow-up report 1.
 
Event Description
The customer reported that the companion 2 driver exhibited a fault alarm while supporting a patient at the hospital (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The customer also reported that after the companion 2 driver was returned to the distributor, the driver did not pass the system check.The companion 2 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 one system malfunction alarm that resulted from an "internal filter blocked" trigger value and one system check failure.The customer experience was confirmed.During investigation testing, the customer-reported system malfunction alarm and the system check failure were duplicated.The root cause was a malfunction of the pressure sensor printed circuit assembly (pca).Despite the customer-reported system malfunction alarm and system check failure, risk to the patient was low because the driver continued to perform its life-sustaining functions.After replacement of the pressure sensor pca, the driver met all performance testing requirements.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 Key5154707
MDR Text Key28707013
Report Number3003761017-2015-00357
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,health pr
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2015
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 Age50 YR
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