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

Model Number SCH740

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem Alteration In Body Temperature (2682)

Event Type  malfunction  

Event Description

When she measured the child's temperature,  the product provided low temperature readings, no more than 36.8 degrees celsius.Later, with another thermometer at a doctor's office, unknown brand and unknown location of measurement, the temperature measured 38.1 degrees celsius.The customer also reported that the child was later admitted to the hospital and was given paracetamol, antibiotics and an iv drip(content unknown).Additional narrative: the device has been requested from consumer.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: 6839302
• MDR Text Key: 84628616
• Report Number: 3009181561-2017-00036
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1