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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 Problems Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
This companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the companion 2 driver did not recognize external batteries.
 
Manufacturer Narrative
The driver in "as received" condition passed all functional test requirements.In addition, external batteries that have previously met performance requirements were used to test the ability of the driver to recognize and charge external batteries, which the driver was able to do.The alarm history was reviewed and revealed battery-related alarms that could have been caused from either from lack of recognition (depleted batteries) or from the batteries being removed as part of the system checkout.The driver will only record alarms and notifications while the driver is on, and the status of any batteries in the driver when the driver is off is not recorded.The external batteries in use at the time of the customer-reported issue were not returned with the driver and therefore were not evaluated.The root cause of this issue cannot be determined without investigating the external batteries, but it is likely that the batteries in use were severely depleted external batteries and not a malfunction of the driver.The driver performed as intended and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
Manufacturer Narrative
The driver in "as received" condition passed all functional test requirements.In addition, external batteries that have previously met performance requirements were used to test the ability of the driver to recognize and charge external batteries, which the driver was able to do.The alarm history was reviewed and revealed battery-related alarms that could have been caused from either from lack of recognition (depleted batteries) or from the batteries being removed as part of the system checkout.The driver will only record alarms and notifications while the driver is on, and the status of any batteries in the driver when the driver is off is not recorded.The external batteries in use at the time of the customer-reported issue were not returned with the driver and therefore were not evaluated.The root cause of this issue cannot be determined without investigating the external batteries, but it is likely that the batteries in use were severely depleted external batteries and not a malfunction of the driver.The driver performed as intended and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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 Key7774228
MDR Text Key116870837
Report Number3003761017-2018-00441
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 08/24/2018
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 Manufacturer08/07/2018
Initial Date Manufacturer Received 08/02/2018
Initial Date FDA Received08/10/2018
Supplement Dates Manufacturer Received08/02/2018
Supplement Dates FDA Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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