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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM CAR CHARGER

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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM CAR CHARGER Back to Search Results
Catalog Number 295053-001
Device Problems Device Inoperable (1663); Device Operational Issue (2914)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the car charger issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom car charger will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
 
Event Description
The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
 
Manufacturer Narrative
A return material authorization (rma) was issued for the return of the car charger; however, the site confirmed it did not return the car charger using the rma and instead shipped it with other equipment.Therefore, when the car charger was received at syncardia without an associated rma, it was discarded per procedure mfg-239, driver receiving and sanitation procedure.This issue will continue to be monitored and trended in the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Manufacturer Narrative
A return material authorization (rma) was issued for the return of the car charger; however, the site confirmed it did not return the car charger using the rma and instead shipped it with other equipment.Therefore, when the car charger was received at syncardia without an associated rma, it was discarded per procedure mfg-239, driver receiving and sanitation procedure.This issue will continue to be monitored and trended in the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
 
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Brand Name
SYNCARDIA FREEDOM CAR CHARGER
Type of Device
CAR CHARGER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7390830
MDR Text Key104414807
Report Number3003761017-2018-00111
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295053-001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
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