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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION CADDY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION CADDY Back to Search Results
Catalog Number 397001-001
Device Problems Sticking (1597); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the issue was observed when the companion driver caddy was not in use by a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion driver caddy will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The companion driver caddy was not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized distributor, reported that the companion driver caddy handle is stuck.
 
Manufacturer Narrative
The companion driver caddy was returned to syncardia for investigation.The customer-reported issue of the caddy handle being stuck was confirmed and duplicated.The root cause of the stuck handle was determined to be caused by a bend in the upper handle assembly, which was most likely the result of rough handling.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 companion driver caddy was not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized distributor, reported that the companion driver caddy handle is stuck.
 
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Brand Name
SYNCARDIA COMPANION CADDY
Type of Device
COMPANION CADDY
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 Key6442881
MDR Text Key71468772
Report Number3003761017-2017-00057
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
Type of Report Initial,Followup
Report Date 03/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number397001-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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