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 COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE
  • 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 COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE Back to Search Results
Catalog Number 397002-001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
This companion 2 driver was not in use by a patient.The customer reported that the companion 2 driver did not recognize wall air while performing a system check.The customer attempted to use different air hoses and a pressure regulator between the wall outlet and air hose without success.This alleged failure mode poses a low risk to a patient, because the issue was observed when the driver was not supporting a patient.In addition, the reported issue would not prevent the companion 2 driver from performing its life-sustaining functions.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
CIRCULATORY ASSIST DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq., vp
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4360298
MDR Text Key5117776
Report Number3003761017-2014-00295
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-