MAUDE Adverse Event Report: COVIDIEN FILAC; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	505003
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit has been repaired, and recertified per procedure.The unit was restored to proper operation.
Event or Problem Description
The unit was sent to a service center for repair.Upon triage, a technician found a burned track on the keyboard.
Additional Manufacturer Narrative
A review of the device history record shows that this unit was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, corrective actions will be taken as necessary.Very little current is required for the keypad overlay to function so it is designed accordingly.For multiple traces to have ¿burned¿, there is either an overvoltage condition or a chemical/liquid ingress occurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FILAC
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 6899671
• Report Number: 3008361498-2017-05445
• Device Sequence Number: 872943
• Product Code: FLL
• UDI-Device Identifier: 10884521104051
• UDI-Public: 10884521104051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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
• Operator of Device: Other
• Device Model Number: 505003
• Device Catalogue Number: 505003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 02/16/2018
• Patient Sequence Number: 1