MAUDE Adverse Event Report: COVIDIEN FILAC 3000 EZ ORAL/AX COMPLETE; THERMOMETER

Model Number 504000

Device Problems Device Emits Odor (1425); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/31/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a thermometer.The customer states that they received a change battery sign.The customer changed the batteries out and then there was a burning and melting wire smell.The read out panel was black.This was contained inside the unit.

Manufacturer Narrative

A review of the device history record shows this device was released meeting all manufacturing specifications.An investigation was performed.After initial review of the information in the complaint file, the complaint was confirmed.The thermometer was disassembled and a visual inspection was performed.Root cause determined to be that c5 on the main pcb had shorted, causing the burning smell.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed at this time.

• Brand Name: FILAC 3000 EZ ORAL/AX COMPLETE
• Type of Device: THERMOMETER
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 5084926373
• MDR Report Key: 5689353
• MDR Text Key: 46915173
• Report Number: 3006451981-2016-00233
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 504000
• Device Catalogue Number: 504000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1