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 POWER ADAPTOR; AC POWER ADAPTOR
  • 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 POWER ADAPTOR; AC POWER ADAPTOR Back to Search Results
Catalog Number 295070-001
Device Problems Break (1069); Component Falling (1105); Unintended Collision (1429); Loss of Power (1475)
Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199); Loss of consciousness (2418)
Event Date 09/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), and freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.The freedom power adaptor will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).Please note that this is a corrected report.The mdr has been changed from a product problem to an adverse event.
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), and (3) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.The freedom power adaptor s/n (b)(4) was returned to syncardia for investigation.Visual inspection of the power adaptor revealed plastic debris inside the input connector, as well as a metal contact piece on the connector pin.The debris was identified as being parts of a freedom ac power supply connector.After the ac power supply connector pieces were removed from the input connector, the power adaptor was tested and passed all functional and performance testing.The power adaptor performed as intended and there was no evidence of a device malfunction.A performance evaluation of the power adaptors revealed no defects impacting the power adaptors' ability to support life sustaining driver functions.A back-up freedom driver system is also provided to every patient, which provides a means for the patient to be switched to the backup driver in the event a functional anomaly is encountered.Freedom power adaptor was serviced and passed all functional and performance testing prior to being placed into finished goods for clinical use.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 POWER ADAPTOR
Type of Device
AC POWER ADAPTOR
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 Key5132276
MDR Text Key28068692
Report Number3003761017-2015-00306
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
Remedial Action Replace
Type of Report Followup
Report Date 09/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295070-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
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 Age58 YR
-
-