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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LUMEON ORAL/AXILLARY THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL
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COVIDIEN LUMEON ORAL/AXILLARY THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number 3074
Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports the device tip gets hot and the unit is delivering inaccurate temperature readings.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The unit passes triage and was inspected for corrosion and liquid ingress.Tips warm up to 96.0f during turn which is used a reference temp for recognizing a probe has been entered patients mouth.Unit temps all pass.Unit has been checked for all upgrades, performance and passes a visual inspection.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
LUMEON ORAL/AXILLARY THERMOMETER
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
COVIDIEN
building 10- no 789 puxing roa
shanghai 20111 4
CN  201114
MDR Report Key7742146
MDR Text Key115922095
Report Number3006451981-2018-00541
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3074
Device Catalogue Number3074
Was Device Available for Evaluation? No
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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