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

Model Number SCH740

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

The customer claims that the device does not provide accurate measurements.She bought the device to be used on her son, who can get fevers that can lead to epileptic attacks.The device is intended to be used by her son's teacher in school.In testing the product, the customer first made a measurement with different devices (anal thermometer), which indicated 38 degrees.Then, the temperature was measured with the actual device and it measured 36.2 degrees.The consumer was also tested with other relatives and it always provides a difference of 0.5 to 1 deg c.The tests were conducted at home at room temperature.The unit is no longer available, thus complaint cannot be confirmed.These devices are designed according to relevant safety standards and passed all compliance tests.

• 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: 6749795
• MDR Text Key: 81243705
• Report Number: 3009181561-2017-00025
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2017

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
• Device Operator: No Information
• Device Model Number: SCH740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1