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

Model Number	505000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Power Problem (3010)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 4/17/2018.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 or Problem Description
The customer did not state a specific issue, but service found the unit did not turn on during triage.The technician found what appears to be burn marks on white connectors on pcba and battery housing assembly.
Additional Manufacturer Narrative
Submission date: (b)(6) 2018 an investigation was performed for an issue discovered during device servicing: the customer did not state a specific issue, but service found the unit did not turn on during triage.The technician found what appears to be burn marks on white connectors on pcba and battery housing assembly.A review of the device history record (dhr) indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.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.An evaluation was performed.Technician observations consisted of burn marks and that the unit would not turn on.Visual inspection found that connector j6 had black marks consistent with thermal damage both on the board connector and the wiring connection.It was also observed that component c5 had damage consistent with a short.No other physical anomalies were observed.Unit was disassembled.Further troubleshooting found that fuse f1 was open, causing the unit to not power on.Cause of the c5 short or thermal damage to the connector was unable to be determined.The main pcba and probe switch pcba were removed and retained.The evaluation confirmed the device condition.There were no signs of customer misuse.The most probable root cause is a component failed causing a short circuit.This incident will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FILAC
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7437935
• Report Number: 3006451981-2018-00282
• Device Sequence Number: 1339419
• Product Code: FLL
• UDI-Device Identifier: 20884521008509
• UDI-Public: 20884521008509
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/29/2023
• Device Model Number: 505000
• Device Catalogue Number: 505000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1