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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; RESPIRATORY GAS HUMIDIFIER
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TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; RESPIRATORY GAS HUMIDIFIER Back to Search Results
Catalog Number 425-00
Device Problems Device Emits Odor (1425); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 01/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation, confirm the alleged defect, and determine a root cause.Customer complaint cannot be confirmed.If the device sample become available at a later date, this complaint will be updated accordingly.
 
Event Description
Customer complaint alleges "heater made a popping sound and then smelled like something burning".Alleged defect was reported prior to use.No report of patient involvement.No report of user harm.It is unclear if the alleged defect was detected in the clinical setting.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit immediately failed the initial power connect test with a red wrench fail mode.The red wrench failure mode represents an internal, unrecoverable failure.The case was opened to try and determine if there was an obvious reason for the burning smell reported by the customer.Upon exposing the internal cavity of the neptune, a significant electrical burn with associated black soot was seen.Based on the investigation performed, the reported complaint was confirmed.When the unit was opened, the source of a burning smell was discovered.A dead short occurred (electrical malfunction where voltage/current is mistakenly directed to ground) at one of the three soldered connections of wiring harness connector 11805/power control/pc/pcb.The electrical short took place between this solder connector pin and a metal insulated plate that provides an insulated partition between the power control pcb and the power supply pcb.This unit had been in use approximately six years before the incident took place.Multiple scenarios could have caused or contributed to the short which are not necessarily tied to any customer activity.A root cause could not be established.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not determined.
 
Event Description
Customer complaint alleges "heater made a popping sound and then smelled like something burning".Alleged defect was reported prior to use.No report of patient involvement.No report of user harm.It is unclear if the alleged defect was detected in the clinical setting.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
RESPIRATORY GAS HUMIDIFIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6389907
MDR Text Key69439867
Report Number3003898360-2017-00177
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2011
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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