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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER
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SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER Back to Search Results
Model Number SCH740
Device Problem Invalid Sensing (2293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Consumer claims that the temperature measurement taken by the device was inaccurate when compared to other devices.The temperature measured with the device was between 36.4 and 37.5 degrees in the ear, while a rectal thermometer, of unknown brand, indicated 38.9 degrees celsius.
 
Manufacturer Narrative
The manufacturer tested the product returned by the consumer.Testing results show that the error in accuracy resulted from the probe tip being soiled.When the tip was cleaned, per the instructions for use, the product measured in accordance to specifications.Consequently, there was no fault found on the device.
 
Event Description
Consumer claims that the temperature measurement taken by the device was inaccurate when compared to other devices.The temperature measured with the device was between 36.4 and 37.5 degrees in the ear, while a rectal thermometer, of unknown brand, indicated 38.9 degrees celsius.
 
Manufacturer Narrative
The manufacturer tested the product returned by the consumer.Testing results show that the error in accuracy resulted from the probe tip being soiled.When the tip was cleaned, per the instructions for use, the product measured in accordance to specifications.Consequently, there was no fault found on the device.On (b)(6) 2017: corrected the become aware date to the correct date, (b)(6) 2017.
 
Event Description
Consumer claims that the temperature measurement taken by the device was inaccurate when compared to other devices.The temperature measured with the device was between 36.4 and 37.5 degrees in the ear, while a rectal thermometer, of unknown brand, indicated 38.9 degrees celsius.
 
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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 Key6562670
MDR Text Key74990176
Report Number3009181561-2017-00007
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/12/2017,04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSCH740
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2017
Distributor Facility Aware Date05/12/2017
Device Age1 YR
Event Location Home
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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