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

Model Number SCH740 (TH3003N)

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

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

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.We checked the dhf/dmr files for this device, there were no problems observed during the checking dhf/dmr files.According to previous experience, the most likely reason that caused inaccurate measurements is that user didn't follow the instructions in the user manual to clean the probe tip.We are currently trying to retrieve the device to investigate it and determine the root cause of the event.

Event Description

A consumer reported that the philips avent smart ear thermometer measured her son's temperature inaccurately (around 36 degrees celsius), which led to delayed treatment and the baby having a febrile seizure.When the healthcare professionals took care of him, his temperature was around 40 degrees celsius.The baby was hospitalized for three days after the event.The baby's health condition has now improved.

• Brand Name: PHILIPS AVENT SMART EAR THERMOMETER
• Type of Device: PHILIPS AVENT SMART EAR THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,nanshan; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, guangdong 51805 7; CH 518057
• Manufacturer Contact: mrs ; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, guangdong 51805-7
• MDR Report Key: 7445926
• MDR Text Key: 106009101
• Report Number: 3005170249-2018-00001
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SCH740 (TH3003N)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other