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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM BATTERY CHARGER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM BATTERY CHARGER Back to Search Results
Catalog Number 295054-001
Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
The freedom battery charger will be returned to syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The customer, a syncardia certified hospital, reported the freedom battery charger was damaged at the ac power supply connector.
 
Manufacturer Narrative
Visual inspection revealed a damaged connector pin on the 2-pin power supply connector.The connector was able to be mated with a freedom home ac power supply but the functional testing was not performed due to electrical risk if connected to a power source.The customer-reported issue was able to be confirmed visually.The root cause of the damage was most likely mishandling or wear and tear.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 BATTERY CHARGER
Type of Device
BATTERY CHARGER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key10254919
MDR Text Key207529372
Report Number3003761017-2020-00153
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 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295054-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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