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

Model Number DL8740

Device Problems Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Event Description

Consumer claims that the device was not working properly and giving wrong measurements.Additional narrative: the device is not available for evaluation, 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: 6750664
• MDR Text Key: 81288691
• Report Number: 3009181561-2017-00034
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL8740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening