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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER AND AVENT SMART EAR THERMOMETER
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SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER AND AVENT SMART EAR THERMOMETER Back to Search Results
Model Number DL8740
Device Problem Invalid Sensing (2293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The consumer is alleging that the thermometer is not functioning properly. the word "lo" appears on the screen every time the consumer has tried to use it.The consumer replaced the battery, but the same error would appear.The consumer was able to finally obtain a temperature reading, but it was the wrong temperature, 92.1deg c. .
 
Manufacturer Narrative
Supplemental #1: the date entered was incorrect.The report has been corrected.The consumer has also indicated that the product will not be returned.
 
Event Description
The consumer is alleging that the thermometer is not functioning properly. the word "lo" appears on the screen every time the consumer has tried to use it.The consumer replaced the battery, but the same error would appear.The consumer was able to finally obtain a temperature reading, but it was the wrong temperature, 92.1 deg c. .
 
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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 Key6438659
MDR Text Key70990024
Report Number3009181561-2017-00004
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2017,02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberDL8740
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2017
Distributor Facility Aware Date02/28/2017
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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