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

Model Number 505000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/16/17.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a thermometer.The customer reports change of batteries was made and when the temperature was taken the screen was burnt.No patient involvement.

Manufacturer Narrative

Regarding the lcd, the covers were removed and the internal electronic cards were checked and no traces of moisture or any signs were found.In addition it was verified that externally there were no traces of strong external blows.Due to the shape of the internal liquid spill on the screen, it seems like a failure to manufacture said lcd screen, since, as mentioned before, there is no indication of any liquid entering the equipment nor any traces of strong external shock.Regarding the temperature sensor, the damage is due to end user manipulation.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 routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿it was reported to covidien on 2/15/2017 that a customer had an issue with a thermometer.The customer reports change of batteries was made and when the temperature was taken the screen was burnt.No patient involvement.¿ the device history record (dhr) for the reported lot number a1350554x indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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 sent to research & development for further evaluation.The observations and results of this evaluation concluded: device internal electronics were covered in fluid residue and contained considerable corrosion.It was determined that liquid ingress caused the corrosion and was the result of customer misuse.The reported customer complaint is confirmed.The root cause of the issue was abundant fluid ingress.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
• Manufacturer (Section G): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6410650
• MDR Text Key: 70418667
• Report Number: 3006451981-2017-05070
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: PE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/28/2023
• Device Model Number: 505000
• Device Catalogue Number: 505000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2013
• 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