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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD DIKANG HBG01; THERMOMETER KIT
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HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD DIKANG HBG01; THERMOMETER KIT Back to Search Results
Model Number HGB01
Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
Event Type  malfunction  
Event Description
The hospital in part of its covid screening process had purchased a number of electronic infrared skin thermometers.The purpose of these skin thermometers were to provide a 1st level of temperature screening of staff and visitors.Since these have been purchased, there has been many repairs performed on these devices including broken triggers, taking a low temp, and not reading accurately.With this being a critical scanning tool/process there is a risk potential in failing to properly screen staff and visitors.
 
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Brand Name
DIKANG HBG01
Type of Device
THERMOMETER KIT
Manufacturer (Section D)
HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD
3907 prince street suite 6f
flushing NY 11354
MDR Report Key10534442
MDR Text Key206965739
Report Number10534442
Device Sequence Number1
Product Code PXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberHGB01
Device Catalogue NumberDIKANG HGB01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2020
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer09/15/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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