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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM POWER ADAPTOR; AC POWER ADAPTOR
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM POWER ADAPTOR; AC POWER ADAPTOR Back to Search Results
Catalog Number 295070-001
Device Problems Device Operates Differently Than Expected (2913); Inadequate Lighting (2957)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the light on the freedom driver power adaptor did not remain lit, it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom driver power adaptor has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer reported that the light on the freedom driver power adaptor did not remain lit.The customer also reported that the power adaptor was replaced with a backup power adaptor without any reported adverse patient impact.
 
Manufacturer Narrative
The freedom driver power adaptor was returned to syncardia for evaluation.During testing, attempts to reproduce the customer-reported issue were unsuccessful.The power adaptor performed as intended and there was no evidence of a blinking light or malfunction.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).
 
Event Description
The customer reported that the light on the freedom driver power adaptor did not remain lit.The customer also reported that the power adaptor was replaced with a backup power adaptor without any reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM POWER ADAPTOR
Type of Device
AC POWER ADAPTOR
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6077580
MDR Text Key59555979
Report Number3003761017-2016-00363
Device Sequence Number1
Product Code LOZ
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 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295070-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2016
Initial Date FDA Received11/03/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2010
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 Age64 YR
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