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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 Problems Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
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 evaluation will be provided in a follow-up mdr.Ce 4040 initial.
 
Event Description
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that when the companion 2 driver was turned on for a training session, the companion external batteries showed 3 leds (60% or less) and the emergency battery light was blinking.The customer also reported that after approximately 30 seconds, the companion 2 driver exhibited an emergency battery error alarm.The customer also reported that when the external batteries were removed, the companion 2 driver powered off.The customer also reported that the companion 2 driver was then plugged into wall power for the weekend and when powered up, the driver exhibited another emergency battery error alarm.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue of an emergency battery error alarm was confirmed through review of the 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.The root cause for 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 an extended period of time before being used for training.It is possible that during this period the driver was not plugged into shore 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 when the companion 2 driver was turned on for a training session, the companion external batteries showed 3 leds (60% or less) and the emergency battery light was blinking.The customer also reported that after approximately 30 seconds, the companion 2 driver exhibited an emergency battery error alarm.The customer also reported that when the external batteries were removed, the companion 2 driver powered off.The customer also reported that the companion 2 driver was then plugged into wall power for the weekend and when powered up, the driver exhibited another emergency battery error alarm.
 
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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
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key7078767
MDR Text Key94903712
Report Number3003761017-2017-00232
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
Type of Report Initial,Followup
Report Date 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
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 Manufacturer12/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2018
Was Device Evaluated by Manufacturer? Yes
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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