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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE Back to Search Results
Catalog Number 397002-001
Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2015
Event Type  malfunction  
Event Description
This companion 2 driver was not supporting a pt.The customer reported that the companion 2 driver did not pass the system check.This alleged failure mode poses a low risk to the pt, because the issue was observed when the companion 2 driver was not supporting a pt.In addition, the reported issue would not prevent the companion 2 driver from performing its life-sustaining functions.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
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 Key4632577
MDR Text Key5755715
Report Number3003761017-2015-00107
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
Remedial Action Repair
Type of Report Initial
Report Date 03/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2015
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 Received03/10/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2014
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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