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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the freedom driver stopped for a few seconds and then restarted with an immediate fault alarm while supporting a patient.The customer also reported that the patient switched to the backup driver without any adverse impact.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed split housings.Visual inspection of the internal components of the driver revealed secondary motor out of bottom dead center (bdc) position and raised insert in bottom right housing boss.The alarm history was reviewed and revealed a fault code produced as a result of the primary motor pausing momentarily and the driver reverting to the secondary motor operation.The driver performed as intended during investigation testing with no evidence of a device malfunction.The customer-reported momentary stop and associated fault alarm could have occurred as a result of the bdc condition noted in the alarm history and visual inspection.The cause of the bdc condition could not be determined based on the information reported.However, it is possible the driver experienced an impact shock or rough handling that caused the motor position to move out of bdc.The evidence for rough handling was observed in visual inspection although it was not reported by the customer.The physical damage suggests that improper use was the root cause of the reported customer experience.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 3822 follow-up report 1.
 
Event Description
The customer, a syncardia certified hospital, reported that the freedom driver stopped for a few seconds and then restarted with an immediate fault alarm while supporting a patient.The customer also reported that the patient switched to the backup driver without any adverse impact.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6637475
MDR Text Key77641885
Report Number3003761017-2017-00098
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 Health Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age52 YR
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