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

Model Number SCH740

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The returned device showed dirt (ear wax) on the tip.When testing the device as returned, the inaccuracy was confirmed, however after being cleaned as per user instructions, the device did perform as per specifications.

Event Description

The user, experiencing fever, reported that the product provided low temperature readings, (no more than 37,5 degrees celsius), wherears 20 minutes later, 38.8 degrees celsuis were measured using an oral thermometer at a doctor's office.

• Brand Name: PHILIPS AVENT SMART EAR THERMOMETER
• Type of Device: THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer Contact: kang jianping ; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, guangdong 51810-8 ; CH 518108
• MDR Report Key: 6957388
• MDR Text Key: 90651465
• Report Number: 3005170249-2017-00010
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SCH740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1