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

Model Number SCH740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

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.

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.Additional narrative: 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 xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer Contact: kang jianping ; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, guangdong 51810-8 ; CH 518108
• MDR Report Key: 6957427
• MDR Text Key: 90587780
• Report Number: 3005170249-2017-00016
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K100488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SCH740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1