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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY Back to Search Results
Catalog Number 295600-001
Device Problems Electrical /Electronic Property Problem (1198); Connection Problem (2900)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom home ac power supply had a poor connection, 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 home ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the patient's freedom home ac power supply had a poor connection.There was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom home ac power supply was returned to syncardia for evaluation.Investigation testing confirmed the customer-reported issue and verified that the freedom home ac power supply has an internal electrical problem that affects the output voltage regulation.However, because the freedom home ac power supply is an off-the-shelf component, no further mechanical disassembly or electrical diagnostic tests were performed by syncardia.The unit will be returned to the supplier for root cause analysis.The results of the supplier evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the patient's freedom home ac power supply had a poor connection.There was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom ac power supply was returned to the supplier for root cause analysis.The root cause of the malfunction was determined to be a leaky diode designator d6.This issue will continue to be monitored and trended as part of the custom experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 2.
 
Event Description
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the patient's freedom home ac power supply had a poor connection.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM HOME AC POWER SUPPLY
Type of Device
AC POWER SUPPLY
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 Key6141099
MDR Text Key61598668
Report Number3003761017-2016-00376
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,Followup
Report Date 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295600-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/29/2016
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 Age53 YR
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