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

Model Number 504003

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/27/2018.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported there was a spark and smoke emitted from the unit and you can clearly smell a burnt smell from inside the unit.The unit was not being used on a patient at the time the user had just changed over the batteries when the problem occurred.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported there was a spark and smoke emitted from the unit and you can clearly smell a burnt smell from inside the unit.The unit was not being used on a patient at the time.The user had just changed over the batteries when the problem occurred.¿ all device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The unit was returned to service for repair.Incoming inspection noted: the unit would not turn on, the flat cable of the keypad was burned and the unit had a burnt odor.Further evaluation identified a defective mainboard.The unit was triaged and the customer¿s reported condition was confirmed.The device was repaired, replacing all affected components.The unit was then tested and passed all functional testing.The reported customer complaint was confirmed.Evaluation for a root cause was based on the limited information in the service notes.A specific root cause was unable to be determined.The potential root cause was determined to be component failure.This complaint will be utilized for tracking and trending purposes.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; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7916008
• MDR Text Key: 121995146
• Report Number: 3006451981-2018-00608
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10884521104037
• UDI-Public: 10884521104037
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 504003
• Device Catalogue Number: 504003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1