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

Model Number SCH740

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

A customer claims that the device measures low temperature values; 33.1degc.Additional narrative: the device is not available from the consumer, thus an evaluation on the actual product cannot be conducted.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: 6746598
• MDR Text Key: 81230150
• Report Number: 3009181561-2017-00020
• 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
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1