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

Model Number SCH740

Device Problem Invalid Sensing (2293)

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

Event Date 03/01/2017

Event Type  malfunction  

Event Description

The product is providing low temperature readings (33.X-35/36 degrees celsius).

Manufacturer Narrative

Follow-up report #1: the consumer returned the product and it was tested by the manufacturer.The test concluded that the thermometer offset by due to a dirty probe tip; removing the impurities provides accurate measurements.

Event Description

The product is providing low temperature readings (33.X-35/36 degrees celcius).

• Brand Name: PHILIPS EAR THERMOMETER AND AVENT SMART 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: 6456160
• MDR Text Key: 71587880
• Report Number: 3009181561-2017-00005
• 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,Followup
• Report Date: 04/04/2017,03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Distributor Facility Aware Date: 03/06/2017
• Device Age: 1 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1