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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); Physical Property Issue (3008)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom home ac power supply cord had frayed, 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 frayed where the cord connects to the black box.The customer also reported that the patient was given a replacement ac home power supply.There was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom home ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom home ac power supply revealed a broken strain relief and a missing hypertronics connector o-ring.This confirms the customer-reported issue.The root cause of the fraying on the power cord could not be conclusively determined; evidence of foreign debris on the strain relief indicates an attempt was made to repair the power cord, which is prohibited.Functional testing showed the freedom home ac power supply to be electrically sound and operating as intended, notwithstanding the visual damage observed during the investigation.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, a syncardia certified hospital, reported that the patient's freedom home ac power supply had frayed where the cord connects to the black box.The customer also reported that the patient was given a replacement ac home power supply.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
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6090042
MDR Text Key59969571
Report Number3003761017-2016-00370
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 11/03/2016
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 Health Professional
Device Catalogue Number295600-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2016
Initial Date FDA Received11/09/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2015
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 Age53 YR
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