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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EKLA CORPORATION NOVAPLUS DIGITAL THERMOMETER
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EKLA CORPORATION NOVAPLUS DIGITAL THERMOMETER Back to Search Results
Catalog Number VDST-100D
Device Problems Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2020
Event Type  malfunction  
Event Description
Rn obtained rectal temperature on pediatric patient multiple times in initial 4 hours of shift.Patient temperature read 98.6 or 98.7 each time.Patient has having difficulty breathing and felt warm to the touch.Rn attempted an alternative route and utilized temporal thermometer which read 100.4.New rectal thermometer obtained and temperature read 100.0.Manufacturer response for digital thermometer, novaplus digital thermometer (per ekla site reporter).Customer service (b)(4) notified of equipment failure.It appeared the lot number was expired.At the request of ekla, i verified that we did not have another thermometer of the same lot number on our shelf.
 
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Brand Name
NOVAPLUS DIGITAL THERMOMETER
Type of Device
DIGITAL THERMOMETER
Manufacturer (Section D)
EKLA CORPORATION
1707 quincy ave. suite 127
naperville IL 60540
MDR Report Key9859709
MDR Text Key184276718
Report Number9859709
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVDST-100D
Device Lot Number20151230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2020
Event Location Hospital
Date Report to Manufacturer03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age42 DA
Patient Weight4
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