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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 Problem Battery Problem (2885)
Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
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.The companion external battery will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
While performing a routine evaluation, a syncardia technician reported that the companion external battery discharge time was outside the testing acceptance criteria.
 
Manufacturer Narrative
During investigation testing, the battery passed all functional procedures.The battery performed as intended with no evidence of a device malfunction.The reason for the battery initially failing the evaluation procedure is most likely due to the tolerance window of the voltage that the battery is allowed to be charged at (currently 16.4 v±0.1v).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.Ce 5041 follow-up report 1.
 
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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 AZ 85713
MDR Report Key9313086
MDR Text Key166137108
Report Number3003761017-2019-00327
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 other
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number293001-001
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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