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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM POWER ADAPTOR; CIRCULATORY ASSIST DEVE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM POWER ADAPTOR; CIRCULATORY ASSIST DEVE Back to Search Results
Catalog Number 295070-001
Device Problems Break (1069); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2014
Event Type  malfunction  
Event Description
The customer reported that the pt experienced a green blinking light on his power adaptor while being supported by the freedom driver.The pt switched the power adaptor without adverse impact.This alleged failure mode poses a low rick to the pt because it did not prevent the freedom driver from performing its life-sustained functions.In addition, the freedom driver has a redundant power source of onboard batteries.The power adapter will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA FREEDOM POWER ADAPTOR
Type of Device
CIRCULATORY ASSIST DEVE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4213806
MDR Text Key19087440
Report Number3003761017-2014-00122
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295070-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
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 Age54 YR
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