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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 Failure to Cycle (1142); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged 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 been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.There was no reported adverse patient impact.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The electronic patient data were reviewed and revealed multiple external air connected notifications.This is an indication that the necessary conditions required for the driver to operate exclusively on external air were not consistently met, thereby causing the driver to disable the external air connected icon and activate the primary compressor.This confirmed the customer-reported issue.Investigation testing determined the root cause to be a malfunction of the manual pressure regulator.Syncardia has a corrective and preventive action (capa) to address the issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.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
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6672129
MDR Text Key78674969
Report Number3003761017-2017-00109
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier0858000003107
UDI-Public(01)0858000003107
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
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 Manufacturer06/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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 Age47 YR
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