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

Model Number DL8740

Device Problems Invalid Sensing (2293); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

The consumer claims that the device's temperature reading, "fluctuates extremely between the set and rectal thermometer." the device reads 38.2c while the normal rectal thermometer reads 39.5c.

Manufacturer Narrative

The wrong manufacturer was inputted.The manufacturer added to this report is the correct one.

Event Description

The consumer claims that the device's temperature reading, "fluctuates extremely between the set and rectal thermometer." the device reads 38.2c while the normal rectal thermometer reads 39.5c.

Manufacturer Narrative

Follow-up report no.1: the wrong manufacturer was inputted.The manufacturer added to this report is the correct one.Follow-up report no.2: the model number and device problem code was changed.Additionally, the device was returned by the consumer and tested by the manufacturer.The test results show the device to be functioning in good condition.The manufacturer has confirmed that the product meets their delivery requirements and it is a qualified product.

Event Description

The consumer claims that the device's temperature reading, "fluctuates extremely between the set and rectal thermometer." the device reads 38.2c while the normal rectal thermometer reads 39.5c.

• Brand Name: AVENT SMART EAR THERMOMETER AND 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: 6267020
• MDR Text Key: 65415843
• Report Number: 3009181561-2017-00002
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017,12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/22/2016
• Event Location: Home
• Date Report to Manufacturer: 01/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1