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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL BATTERY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL BATTERY Back to Search Results
Catalog Number 293001-001
Device Problem Failure to Charge (1085)
Patient Problem No Patient Involvement (2645)
Event Date 09/10/2014
Event Type  malfunction  
Event Description
This companion external battery was not in use by a patient.A syncardia clinical support specialist reported that this companion external battery was unable to charge and was not recognized by a companion 2 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 patient use.In addition, this alleged failure mode would not prevent a companion 2 driver from performing its life-sustaining functions.The companion 2 driver has multiple power sources: external wall power, external batteries and an internal emergency battery.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA COMPANION EXTERNAL BATTERY
Type of Device
BATTERY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, vp, esq
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4272404
MDR Text Key18627711
Report Number3003761017-2014-00177
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2014
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 Received09/10/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2014
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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