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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN FILAC

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COVIDIEN FILAC Back to Search Results
Model Number 504000
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
The unit was sent to a service center for repair.Upon triage, a technician found the pcb to have thermal damage on the right bottom area.The pins were burnt and a cavity was seen, filled with black residue.Black residue was also observed on the components surrounding the pins and fuse.It was unclear if these components suffered thermal damage.
 
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Brand Name
FILAC
Manufacturer (Section D)
COVIDIEN
building 10- no 789 puxing roa
shanghai 20111 4
CN  201114
Manufacturer (Section G)
COVIDIEN
building 10- no 789 puxing roa
shanghai 20111 4
CN   201114
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6798564
MDR Text Key83009526
Report Number3006451981-2017-05509
Device Sequence Number1
Product Code FLL
UDI-Device Identifier20884521008455
UDI-Public20884521008455
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2017
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 Other
Device Expiration Date05/07/2023
Device Model Number504000
Device Catalogue Number504000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Initial Date Manufacturer Received 07/19/2017
Initial Date FDA Received08/16/2017
Date Device Manufactured05/17/2013
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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