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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited a system malfunction alarm while the patient was getting into the hospital elevator.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a system malfunction alarm, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited a system malfunction alarm while the patient was getting into the hospital elevator.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.The system malfunction alarm observed by the customer was confirmed through a review of the patient file.Attempts to duplicate the system malfunction alarm were unsuccessful through normal and simulated operation of the driver.The root cause of the customer-reported system malfunction alarm could not be determined, and there was no evidence of a device malfunction.It is possible that the key switch may have been bumped and moved out of position long enough to result in the system malfunction alarm.During testing, the system malfunction alarm could only be generated through manipulation of the key switch.Although the driver was supporting a patient at the time of the system malfunction alarm, the risk to the patient was low because the system malfunction alarm did not prevent the driver from performing its life-sustaining functions.There was no change to the pumping of the driver or to the patient's condition.The companion 2 driver was serviced and passed all functional and performance testing before being placed into finished goods.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.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5340199
MDR Text Key35355650
Report Number3003761017-2015-00439
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 12/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age46 YR
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