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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM AC POWER SUPPLY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295050-001
Device Problems Crack (1135); Mechanical Problem (1384)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the freedom ac power supply was cracked on the white port.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the ac power supply revealed a cracked housing, a broken strain relief and a cracked connector cover, confirming the reported issue.The cracked housing and broken strain relief can occur as part of normal wear and tear.The cracked connector cover can occur as a result of an impact shock.During the investigation, the ac power supply was tested.Despite the observed damage, the ac power supply was able to connect to a power adaptor and provide power to a freedom driver, and it passed all functional testing.The ac power supply was taken out of service because of the damage observed during the investigation.The reported issue posed a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.In addition, patients are provided with backup ac power supplies, and the freedom driver has a redundant power source of onboard batteries.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 ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the freedom ac power supply was cracked on the white port.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM 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 Key5929632
MDR Text Key54587312
Report Number3003761017-2016-00304
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 08/18/2016
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 Number295050-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2016
Initial Date FDA Received09/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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 Age57 YR
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