Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD PHILIPS EAR THERMOMETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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  
Manufacturer Narrative
The product was received from the consumer and sent to the manufacturer for evaluation.
 
Event Description
The consumer claims that the device measured low values on his child.He alleges that the temperature measures a difference of 1,5, -2 and 0deg c when compared to a rectal thermometer.The child visited a doctor who confirmed the low measurements.
 
Manufacturer Narrative
The product was received from the consumer and sent to the manufacturer for evaluation.The device was tested by the manufacturer and was found to work in accordance to specifications.
 
Event Description
The consumer claims that the device measured low values on his child.He alleges that the temperature measures a difference of 1,5, -2 and 0 deg c when compared to a rectal thermometer.The child visited a doctor who confirmed the low measurements.Additional information: the device returned from the consumer was found to be working in accordance to specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6636102
MDR Text Key77396855
Report Number3009181561-2017-00011
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
Report Date 06/12/2017,05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2017
Distributor Facility Aware Date06/08/2017
Device Age1 YR
Event Location Home
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age18 MO
-
-