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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK Back to Search Results
Catalog Number 293001-001
Device Problems Failure to Charge (1085); Loss of Power (1475); Charging Problem (2892)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial (1 of 2).
 
Event Description
The reported issue involves two companion external batteries that are reported under two separate medical device reports: companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00261) and companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00262).The companion external battery was not supporting a patient.The customer reported that the companion external battery would not charge.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not supporting a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a redundant, alternate power source of external wall power.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The companion external battery was returned to syncardia for evaluation.The customer-reported issue that the companion external battery would not charge was incorrect based on review of system management bus (smbus) data.The companion external battery was received in a state of deep discharge, and was in a recovery mode (zvchg), which could cause an observer to perceive that the companion external battery was not operating as intended.Even though it was charging at an extremely low rate because of the state it was in, given an extended charging interval (36-48 hours) the external battery would have recovered to full charge.Following the low voltage recovery process, the companion external battery passed all test sections of the evaluation procedure.The root cause of the deep discharge cannot be absolutely determined, but given that the customer-reported issue stated that the external battery was not in patient use, a potential cause is that the external battery was left in a driver that was being stored without external power connected.This method of storage can cause the external batteries to enter into zvchg mode.The companion 2 operator manual (c2-900005 rev 013) states that companion 2 drivers should be stored in a hospital cart or caddy that is connected to external (wall) power.External batteries may be stored in a driver that is plugged in, or separately from the driver.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 (1 of 2).
 
Event Description
The reported issue involves two companion external batteries that are reported under two separate medical device reports: companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00261) and companion external battery s/n (b)(4) (mfr report # 3003761017-2016-00262).The companion external battery was not supporting a patient.The customer reported that the companion external battery would not charge.
 
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Brand Name
SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
Type of Device
BATTERY PACK
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 Key5795181
MDR Text Key50355503
Report Number3003761017-2016-00261
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 07/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number293001-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2014
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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