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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 Problem Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver made a "groaning" noise while supporting a patient.The customer also reported that the noise happened over the course of multiple days.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited an unusual noise, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a followup mdr.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation during investigation testing, the reported groaning noise was reproduced.The source of the noise was determined to be the left compressor.Ce (b)(4) follow-up report 1.
 
Event Description
The customer reported that the companion 2 driver made a "groaning" noise while supporting a patient.The customer also reported that the noise happened over the course of multiple days.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
 
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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
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5923586
MDR Text Key54411904
Report Number3003761017-2016-00314
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 08/28/2016
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 Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2016
Initial Date FDA Received09/01/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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 Age56 YR
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