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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIT DEVICE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIT DEVICE Back to Search Results
Catalog Number 397002-001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
The customer reported that the companion 2 driver did not recognize wall air while supporting a pt.The customer attempted to use different airhoses and a pressure regulator between the wall outlet and airhose without success.The pt was switched to the backup driver.There was no adverse impact.This alleged failure mode poses a low risk to the pt because it did not prevent the companion 2 driver from performing.An investigation will be conducted by syncardia.The result of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
CIRCULATORY ASSIT 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 Key4359953
MDR Text Key5239235
Report Number3003761017-2014-00280
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
Remedial Action Replace
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 Received12/15/2014
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 Received11/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2013
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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