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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 397002-001
Device Problem Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a system malfunction alarm, it continued to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that when changing the right vacuum, the companion 2 driver exhibited a system malfunction alarm while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
Event Description
The customer, a syncardia certified hospital, reported that when changing the right vacuum, the companion 2 driver exhibited a system malfunction alarm while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The customer-reported system malfunction alarm was verified through a patient file review and coincided with a loss of vacuum performance and was reproduced during investigation testing.The root cause was determined to be a loss of the right vacuum caused by a damaged solder joint at j19 on the main board printed circuit assembly.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7049631
MDR Text Key93689085
Report Number3003761017-2017-00230
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number397002-001
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/08/2017
Initial Date FDA Received11/21/2017
Supplement Dates Manufacturer Received04/23/2018
Supplement Dates FDA Received05/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age34 YR
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