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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 Material Frayed (1262); Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because this issue 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.
 
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 freedom home ac power supply cable was frayed.
 
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 freedom home ac power supply cable was frayed.
 
Manufacturer Narrative
The freedom home ac power supply was returned to syncardia for evaluation.Visual inspection found missing feet, a broken strain relief and a frayed cable at the location of the other strain relief, thus confirming the customer-reported issue.Functional inspection was not performed as the observed damage on the ac power supply was significant enough that energizing the unit could pose a safety risk.The root cause of the observed damage could not be determined, but is 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.
 
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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
MDR Report Key7229347
MDR Text Key98854188
Report Number3003761017-2018-00042
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295600-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Was the Report Sent to FDA? No
Date Manufacturer Received05/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
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