Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295050-001
Device Problems Difficult to Remove (1528); Failure to Disconnect (2541)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
This freedom ac power supply was not in patient use.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the freedom ac power supply gets stuck and is difficult to remove from the freedom battery charger.This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom ac power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
This freedom ac power supply was not in patient use.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the freedom ac power supply gets stuck and is difficult to remove from the freedom battery charger.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom hospital ac power supply revealed that the cable connector cover was installed in the incorrect orientation.The connector cover key tab was not aligned with the connector key slot, and the connector key slot was not aligned with the connector cover key tab.The incorrect orientation of the connector cover was identified as the root cause of the customer-reported difficulty in disconnecting the hospital ac power supply from the freedom battery charger.The hospital ac power supply connector cover also had a hairline crack, which likely resulted from excessive force that was applied to the connector in an effort to mate it with the keyed receptacle on the battery charger.This crack further impaired proper fitment of the connector.Incoming inspection requirements were improved to clearly identify the correct removal and replacement of the connector cover.The hospital ac power supply cable was disassembled, the connector key slot was aligned with the connector cover key tab, and the correct mating configuration was obtained.After the hospital ac power supply cable was reassembled, it was connected to a properly functioning test battery charger, loaded with four freedom onboard batteries.All four onboard batteries were successfully charged to full capacity.The customer reported issue poses a low risk to a patient because the freedom hospital ac power supply was not in use by a patient at the time of the customer reported issue.In addition, it would not prevent a freedom driver from performing its life-sustaining functions.The freedom driver is equipped with redundant power sources, including an additional ac power supply, multiple rechargeable freedom onboard batteries and a car charger.The hospital ac power supply was taken out of service.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNCARDIA FREEDOM AC POWER SUPPLY
Type of Device
AC POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5186349
MDR Text Key30323750
Report Number3003761017-2015-00370
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 faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295050-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-