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

Model Number 505003

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The unit was sent to a service center for repair.Upon triage, a technician found a burned track on the keyboard.

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
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6899671
• MDR Text Key: 87741688
• Report Number: 3008361498-2017-05445
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10884521104051
• UDI-Public: 10884521104051
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2008
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1