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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
Catalog 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 03/21/2018
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 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 companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an emergency battery alarm despite being plugged into wall power.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue was confirmed through review of the driver's patient and alarm history data and investigation testing.Communication with the emergency battery could not be established, indicating that the emergency battery was below the cut-off voltage and was deeply depleted.It is suspected that the emergency battery was permanently faulted.The root cause of the depleted emergency battery could not be conclusively determined based upon the information provided; however, review of the driver data indicates that the driver was stored and not in use for approximately four months until an emergency battery error alarm was observed and then another two months before two additional emergency battery error alarms were observed.It is possible that during this period the driver was not plugged into wall power, which would have caused the emergency battery to become depleted.The companion 2 driver system operator manual (c2-900005) provides guidance on driver storage requirements in section 12.10, which states "always store companion 2 drivers in a hospital cart or caddy that is connected to external (wall) power." 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.
 
Event Description
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an emergency battery alarm despite being plugged into wall power.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue was confirmed through review of the driver's patient and alarm history data and investigation testing.Communication with the emergency battery could not be established, indicating that the emergency battery was below the cut-off voltage and was deeply depleted.It is suspected that the emergency battery was permanently faulted.The root cause of the depleted emergency battery could not be conclusively determined based upon the information provided; however, review of the driver data indicates that the driver was stored and not in use for approximately four months until an emergency battery error alarm was observed and then another two months before two additional emergency battery error alarms were observed.It is possible that during this period the driver was not plugged into wall power, which would have caused the emergency battery to become depleted.The companion 2 driver system operator manual (c2-900005) provides guidance on driver storage requirements in section 12.10, which states "always store companion 2 drivers in a hospital cart or caddy that is connected to external (wall) power." 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.
 
Event Description
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an emergency battery alarm despite being plugged into wall power.
 
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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 Key7434442
MDR Text Key105685454
Report Number3003761017-2018-00106
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/21/2018
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 Other Health Care Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/21/2018
Initial Date FDA Received04/16/2018
Supplement Dates Manufacturer Received04/20/2018
Supplement Dates FDA Received05/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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