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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNDARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE
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SYNCARDIA SYSTEMS, INC. SYNDARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE Back to Search Results
Catalog Number 397002-001
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2014
Event Type  malfunction  
Event Description
The companion 2 driver was not in use by a pt.The customer reported that the companion 2 driver did not pass the system check after several attempts.This alleged failure mode poses a low risk to a pt, because the issue was observed when the companion 2 driver was not supporting a pt.The companion 2 driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNDARDIA COMPANION 2 DRIVER
Type of Device
CIRCULATORY ASSIST DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq, vp resugator
1992 e. silverlake rd.
ce 2479
tucson, AZ 85713
5205451234
MDR Report Key4360776
MDR Text Key17936133
Report Number3003761017-2014-00279
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2014
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 Received11/19/2014
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
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