MAUDE Adverse Event Report: COVIDIEN FILAC 3000 EZ RECTAL COMPLETE; FILAC THERMOMETER

Model Number 504005

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with a filac thermometer.Upon triage on (b)(6) 2016 the service tech found that the unit had a burn smell after opening the unit.

Manufacturer Narrative

An evaluation of the filac thermometer was performed for the reported condition of, ¿power issue¿.The unit was triaged and the reported issue was confirmed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Possible root causes are: improper handling of the electrical boards, bad component, liquid or chemical ingress.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FILAC 3000 EZ RECTAL COMPLETE
• Type of Device: FILAC 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: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6069612
• MDR Text Key: 59126959
• Report Number: 3006451981-2016-00550
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 504005
• Device Catalogue Number: 504005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• 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: Unknown
• Patient Sequence Number: 1