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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDAN INSTRUMENTS INC; MONITOR,BP,SPO2,ORAL TEMP
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EDAN INSTRUMENTS INC; MONITOR,BP,SPO2,ORAL TEMP Back to Search Results
Catalog Number MDSM3ASNTC
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported by the customer that smoke is coming from the unit where the power cord gets attached to the unit.Per the customer the patient was not connected at the time the smoke was noted, the device was charging with its original cord.The sample was returned for evaluation and the customer reported issue was confirmed.The sample was confirmed to have burn mark on the units pcb board.Functional testing was performed and the device passed spo2, nibp, and temperature tests.A definitive root case could not be determined at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
It was reported by the customer that smoke is coming from the unit where the power cord gets attached to the unit.Per the customer the patient was not connected at the time the smoke was noted, the device was charging with its original cord.
 
Manufacturer Narrative
D.3 updated manufacturers information.
 
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Type of Device
MONITOR,BP,SPO2,ORAL TEMP
Manufacturer (Section D)
EDAN INSTRUMENTS INC
no. 15 jinhui rd
shenzhen, pingshan IL 51812 2
CH  518122
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key13725539
MDR Text Key289767536
Report Number1417592-2022-00028
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberMDSM3ASNTC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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