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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 Failure to Charge (1085); Erratic or Intermittent Display (1182); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
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 is not charging the freedom onboard batteries in the freedom driver that was supporting a patient.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
(b)(4) follow-up report 1.
 
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 is not charging the freedom onboard batteries in the freedom driver that was supporting a patient.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.The freedom hospital ac power supply was returned to syncardia for evaluation.The hospital ac power supply met the functional and electrical test acceptance criteria.There was no evidence of a blinking led on the hospital ac power supply when it was connected to a power adaptor.The hospital ac power supply was connected to a properly functioning test battery charger with four freedom onboard batteries that each had only one bar illuminated on the charge level indicator.The led on the ac power supply remained illuminated and did not exhibit any blinking during the charging process.All four onboard batteries charged to full capacity.The customer-reported issues could not be duplicated.The hospital ac power supply performed as intended.Despite the customer-reported issues, risk to the patient was low because the freedom driver would not have been prevented from performing its life-sustaining functions.The freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and a backup ac power supply.Because the freedom hospital ac power supply did not meet the visual inspection acceptance criteria, it 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 Key5383840
MDR Text Key36916452
Report Number3003761017-2016-00017
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 01/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2016
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 Manufacturer01/26/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2015
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 Age30 YR
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