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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION LI-POLYMER BATTERY PACK
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION LI-POLYMER BATTERY PACK Back to Search Results
Catalog Number 293001-001
Device Problems Break (1069); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
This companion external battery was not in use by a patient.The customer reported that the companion external battery had a broken connector.This alleged failure mode poses a low risk to a patient because the issue was observed when the battery was not in use by a patient.In addition, the reported issue would not prevent the driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of an internal emergency battery and external wall power.Syncardia will conduct an investigation, and the results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA COMPANION LI-POLYMER BATTERY PACK
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq, vp
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4265009
MDR Text Key21843092
Report Number3003761017-2014-00219
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2014
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 Health Professional
Device Catalogue Number293001-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/02/2014
Initial Date FDA Received10/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2011
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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