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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK Back to Search Results
Catalog Number 293001-001
Device Problems Disconnection (1171); Device Displays Incorrect Message (2591); Battery Problem (2885); Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2015
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the low run time of the batteries did not prevent the driver from performing its life-sustaining functions.In addition, when docked in the hospital cart, the companion 2 has a redundant power source of external wall power.The companion external li-battery packs will be returned to syncarida for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
Event Description
The reported issue involves two companion external li-battery packs that are reported under two separate medical device reports: companion external li-battery pack s/n (b)(4 and companion external li-battery s/n (b)(4) (mfr report # 3003761017-2015-00242).The customer reported that when the companion hospital cart was disconnected from external wall power, the hospital cart displayed 1 minute and 40 seconds of battery run time.The customer also reported that the displayed run time jumped to 17 minutes.The customer also reported that the batteries were switched and that the problem did not reoccur.There was no reported patient impact.
 
Manufacturer Narrative
(b)(4) fup 1 - 1 of 2.
 
Event Description
The reported issue involves two companion external li-battery packs that are reported under two separate medical device reports: companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00240) and companion external li-battery s/n (b)(4) (mfr report # 3003761017-2015-00242).The customer reported that when the companion hospital cart was disconnected from external wall power, the hospital cart displayed 1 minute and 40 seconds of battery run time.The customer also reported that the displayed run time jumped to 17 minutes.The customer also reported that the external batteries were switched and that the problem did not reoccur.There was no reported patient impact.Companion external battery s/n (b)(4) was returned to syncardia for evaluation.Visual inspection revealed no damage or anomalies.The external battery was connected to battery evaluation software, and it communicated as expected and exhibited no permanent faults or error flags.After the external battery was fully charged, it was docked into a companion 2 driver, and it passed all functional testing and performed as intended.There was no evidence of a device malfunction.The companion 2 driver system operator manual, at chapter 13, "power management," instructs the user that: " after disconnecting from wall power, the companion 2 driver display (counter) will take approximately one minute to update the estimated battery support time based on driver settings." the reported issue posed a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources, which include external wall power and an internal, emergency battery.In addition, all power sources are continually monitored by the companion 2 driver, with audible and visual alarms to annunciate any potential issues with the driver's power sources.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 EXTERNAL LI-BATTERY PACK
Type of Device
BATTERY PACK
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 Key4995974
MDR Text Key23933464
Report Number3003761017-2015-00240
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Followup
Report Date 07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2015
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 Manufacturer07/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
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 Age47 YR
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