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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 Mechanical Problem (1384); Device Inoperable (1663)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
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 certified hospital, reported that the companion 2 driver locking mechanism does not work.
 
Manufacturer Narrative
Corrected data: serial number.The caddy serial number on the label became faded over time.As a result, (b)(4) was used as the serial number for tracking purposes while it was in the field.When the caddy was returned to syncardia, the serial numbers of the internal circuit boards were cross-referenced with the device history record files and determine that the assigned caddy serial number is (b)(4).(b)(4) follow-up report 2.
 
Manufacturer Narrative
Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion driver caddy s/n (b)(4) indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
Manufacturer Narrative
Visual inspection confirmed the customer-reported issue of the companion 2 driver locking mechanism not working properly as the release plunger assembly was observed to be stuck in the open position.This is a known issue that has been previously documented and investigated; it determined that a lack of internal lubrication was the root cause for the release plunger assembly to be stuck in the open or closed positions.The device history records review of companion driver caddy s/n (b)(4) indicated that the release plunger assembly was installed prior to the most current drawing, and was therefore replaced in accordance with the caddy service shop order when it was returned from the field.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
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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
MDR Report Key7267977
MDR Text Key100254020
Report Number3003761017-2018-00009
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397001-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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