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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 595000-001
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the ac power adaptor on the freedom driver exhibited a blinking light, it did not prevent the freedom driver from performing its life sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the ac power adaptor on the freedom driver exhibited a blinking light while plugged in.The customer also reported that the patient was switched to a backup freedom driver without any adverse patient impact.
 
Manufacturer Narrative
The customer-reported blinking led on the power adaptor of the freedom driver was not able to be confirmed or reproduced during investigation testing.The power adaptor and the driver passed all functional tests.The freedom driver performed as intended with no evidence of a device malfunction.Despite the customer-reported issue not being confirmed or able to be reproduced, syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7995412
MDR Text Key124814608
Report Number3003761017-2018-00495
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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
Type of Report Initial,Followup
Report Date 01/09/2019
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 Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Initial Date Manufacturer Received 10/04/2018
Initial Date FDA Received10/23/2018
Supplement Dates Manufacturer Received10/04/2018
Supplement Dates FDA Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
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