MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER

Model Number SCH740

Device Problem Invalid Sensing (2293)

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

Event Type  malfunction  

Manufacturer Narrative

Device was not available for investigation, therefore we cannot confirm it does perform according to specifications.However, based on previous investigations, we know that inaccurate measurements are typically due to poor cleaning of the thermometer sensor.We have received 5 similar cases; all 5 devices were returned with earwax on the tip.After being properly cleaned according to the instructions provided in the user manual, the 5 devices did all perform according to specifications.This product has been designed according to relevant safety standards, including en12470-5 ( clinical thermometers.Performance of infra-red ear thermometers), and passed all compliance tests.

Event Description

A customer claimed that the temperature measurement made by with sch740 was inaccurate, in comparison with other device.The temperature measured with sch740 was 36.8 in the ear.A rectal thermometer (unknown brand) indicated 38.9 degrees celsius.

Manufacturer Narrative

Device was not available for investigation, therefore we cannot confirm it does perform according to specifications.However, based on previous investigations, we know that inaccurate measurements are typically due to poor cleaning of the thermometer sensor.We have received 5 similar cases; all 5 devices were returned with earwax on the tip.After being properly cleaned according to the instructions provided in the user manual, the 5 devices did all perform according to specifications.This product has been designed according to relevant safety standards, including en12470-5 (clinical thermometers.Performance of infra-red ear thermometers), and passed all compliance tests.The device was returned by the consumer and tested in accordance to specifications.

Event Description

A customer claimed that the temperature measurement made by with sch740 was inaccurate , in comparison with other device.The temperature measured with sch740 was 36.8 in the ear.A rectal thermometer (unknown brand) indicated 38.9 degrees celsius.The device returned by the consumer tested in accordance to the product's specifications.

• Brand Name: PHILIPS EAR THERMOMETER
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD; no. 3 building xilibaimang; xusheng, industrial estate; nanshan, shenzhen, cn-44 51810 8; CH 518108
• MDR Report Key: 6681114
• MDR Text Key: 78827423
• Report Number: 3009181561-2017-00015
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017,04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SCH740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2017
• Distributor Facility Aware Date: 06/22/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1