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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 Date 03/02/2017
Event Type  malfunction  
Event Description
The user, experiencing fever, reported that the product provided low temperature readings, (no more than 37,5 degrees celsius), whereas 20 minutes later, 38.8 degrees celsius were measured using an oral thermometer at a doctor's office.
 
Manufacturer Narrative
The product was returned by the consumer and investigated by the manufacturer.The investigation concluded that the product functions in accordance to the specifications; the inaccuracy claimed was due to the probe tip being dirty.The user manual provides instructions for cleaning the device.
 
Event Description
The user, experiencing fever, reported that the product provided low temperature readings, (no more than 37,5 degrees celsius), whereas 20 minutes later, 38.8 degrees celsius were measured using an oral thermometer at a doctor's office.
 
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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 Key6503652
MDR Text Key73221886
Report Number3009181561-2017-00006
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/19/2017,03/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2017
Distributor Facility Aware Date03/22/2017
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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