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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (
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HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 425-00
Device Problem Insufficient Heating (1287)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges unit is not heating prior to use on patient.No patient involvement reported.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer complaint alleges unit is not heating prior to use on patient.No patient involvement reported.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
MDR Report Key10859812
MDR Text Key216848354
Report Number3003898360-2020-00938
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K131912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/13/2020
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 No Information
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/13/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received11/18/2020
Supplement Dates FDA Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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