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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 Difficult to Remove (1528); Sticking (1597)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
The companion driver caddy has been 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 driver caddy handle is stuck.
 
Manufacturer Narrative
The companion driver caddy was returned to syncardia for investigation.The customer-reported issue of a jammed handle was confirmed and duplicated during investigation testing.The root caused was determined to be a bent handle latch assembly.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this investigation 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 certified hospital, 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 Key6799023
MDR Text Key83139510
Report Number3003761017-2017-00143
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
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 Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/25/2017
Was Device Evaluated by Manufacturer? Yes
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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