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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 397002-001
Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the compressor cycling did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.There was no reported adverse patient impact.
 
Manufacturer Narrative
The customer-reported compressor cycling on the companion 2 driver was confirmed via review of the driver's alarm history and was reproduced during investigation testing.The root cause of the compressor cycling was determined to be a malfunction of the manual pressure regulator, which was unable to maintain the required pressure set point value.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
Manufacturer Narrative
The customer-reported compressor cycling on the companion 2 driver was confirmed via review of the driver's alarm history and was reproduced during investigation testing.The root cause of the compressor cycling was determined to be a malfunction of the manual pressure regulator, which was unable to maintain the required pressure set point value.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7358322
MDR Text Key103286775
Report Number3003761017-2018-00090
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number397002-001
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Was the Report Sent to FDA? No
Date Manufacturer Received03/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age27 YR
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