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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION HOSPITAL CART Back to Search Results
Catalog Number 397003-001
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external batteries and an internal emergency battery.The companion ac power cord 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 syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The hospital cart can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia certified hospital, reported that the companion ac power cord was unable to lock securely in place to the companion hospital cart used by the patient.The customer also reported that the patient was provided a new companion ac power cord.There was no reported adverse patient impact.
 
Manufacturer Narrative
The companion ac power cord was returned to syncardia for evaluation.The reported issue of the power cord not locking was confirmed, as the power cord was not able to lock in place during investigational testing with receptacles on five different hospital carts.A corrective and preventive action (capa) was opened for the issue of power cords not staying in place and was closed due to the implementation of iec power cord locks.This is the first instance of the new iec power cord lock not locking.This issue will continue to be monitored through the customer experience process.Syncardia has completed its evaluation of this complaint is closing this file.(b)(4) follow-up report 1.
 
Event Description
The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The hospital cart can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia certified hospital, reported that the companion ac power cord was unable to lock securely in place to the companion hospital cart used by the patient.The customer also reported that the patient was provided a new companion ac power cord.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA COMPANION HOSPITAL CART
Type of Device
HOSPITAL CART
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 Key6339495
MDR Text Key68085258
Report Number3003761017-2017-00040
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397003-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/22/2017
Was Device Evaluated by Manufacturer? Yes
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 Age55 YR
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