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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY; EXTERNAL POWER SUPPLY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY; EXTERNAL POWER SUPPLY Back to Search Results
Catalog Number 295600-001
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
The freedom home ac power supply will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom home ac power supply had a damaged cord.
 
Manufacturer Narrative
Visual inspection of the power supply revealed torn black outer insulation on the ac line cord.Despite the observed damage, the power supply was still able to connect to the power adapter and power a freedom driver.The root cause of this damage could not be determined, but it is most likely due to mishandling, or wear and tear of the product.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA FREEDOM HOME AC POWER SUPPLY
Type of Device
EXTERNAL POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key11150479
MDR Text Key226238163
Report Number3003761017-2021-00003
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
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295600-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2021
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
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