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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. COMPANION EXTERNAL BATTERY
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SYNCARDIA SYSTEMS, INC. COMPANION EXTERNAL BATTERY Back to Search Results
Catalog Number 293001-001
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 12/31/2013
Event Type  malfunction  
Event Description
This companion external battery was not in use by a patient.The customer reported that the indicator lights on the companion external battery were not working and when it was inserted in a companion 2 driver, the battery was not recognized by the driver.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not in use by a patient.In addition, it would not prevent a companion 2 driver from performing its life-sustaining functions, because companion 2 drivers have redundant sources of power.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
COMPANION EXTERNAL BATTERY
Type of Device
BATTERY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq., vp
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key3694959
MDR Text Key4246478
Report Number3003761017-2014-00019
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 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number293001-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/31/2013
Was Device Evaluated by Manufacturer? No
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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