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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295050-001
Device Problems Break (1069); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2015
Event Type  malfunction  
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 cable on a patient's freedom ac power supply was damaged.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 function.The freedom driver continued to function as intended.The freedom driver has redundant power source of onboard batteries.An investigation will be conducted by syncardia.The results fo the investigation will be provided in a supplemental mdr.
 
Manufacturer Narrative
(b)(4) follow-up report 1.Please note that the serial number has been corrected from s/n (b)(4) to s/n (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 cable on a patient's freedom ac power supply was damaged.The patient was provided with a replacement ac power supply.There was no reported adverse patient impact.The freedom ac power supply was returned to syncardia for evaluation.Physical inspection of the freedom ac power supply revealed a damaged strain relief on the power adaptor cable, confirming the reported issue.The root cause of the damaged strain relief cannot be determined but is consistent with the result of normal use.The ac power supply passed functional testing.This failure mode poses a low risk to the patient because it would not prevent the freedom driver from performing its life-sustaining functions.The damaged strain relief was a cosmetic issue and did not affect the functionality of the freedom power supply.Similarly, there was no evidence of compromised cable insulation that could cause any harm to the end user.The freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and a backup ac power supply.Because of the damaged strain relief, freedom ac power supply was taken out of service.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.
 
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Brand Name
SYNCARDIA FREEDOM AC POWER SUPPLY
Type of Device
AC POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key4995970
MDR Text Key24554302
Report Number3003761017-2015-00248
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Followup
Report Date 08/04/2015
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 Other Health Care Professional
Device Catalogue Number295050-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/10/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2014
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 Age58 YR
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