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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 Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom home ac power supply made a rattling noise and the light did not stay on, 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 reported that the patient reported that the freedom home ac power supply made a rattling noise.The customer also reported that the patient reported that the light on the freedom home ac power supply does not turn on unless it is shaken.
 
Manufacturer Narrative
The (b)(6) ac power supply was returned to (b)(4) for evaluation.The presence of a rattling sound emanating from inside the home ac power supply was confirmed while changing the physical orientation of the unit to conduct the visual inspection.Investigation testing determined that home ac power supply was inoperable in its as-received condition, thereby confirming the customer-reported issue.However, because the (b)(6) ac power supply is an off-the-shelf component, no further mechanical disassembly or electrical diagnostic tests were performed by (b)(4).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 (b)(6) ac power supply is a component that enables the (b)(6) driver to be plugged into an external power source.The customer reported that the patient reported that the (b)(6) ac power supply made a rattling noise.The customer also reported that the patient reported that the light on the (b)(6) ac power supply does not turn on unless it is shaken.
 
Manufacturer Narrative
The freedom home ac power supply was returned to the supplier for evaluation.Visual inspection of the external components by the supplier revealed cracked and chipped cover.Visual inspection of the internal components by the supplier revealed a broken lead on an inductor.The supplier determined the root cause of the customer-reported issue of a rattling noise (loose inductor) was severe impact.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 freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient reported that the freedom home ac power supply made a rattling noise.The customer also reported that the patient reported that the light on the freedom home ac power supply does not turn on unless it is shaken.
 
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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 Key6063809
MDR Text Key59029955
Report Number3003761017-2016-00362
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 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
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 Manufacturer11/02/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2015
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 Age57 YR
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