Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 425-00
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
Qn#(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.It is necessary to receive the physical device sample to perform a proper investigation and confirm the alleged defect.Customer complaint cannot be confirmed.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.
 
Event Description
Customer complaint alleges the control panel of the device is not displaying fully and therefore cannot access controls for the device settings.Alleged malfunction reported as detected during patient use.It was reported there was no patient injury or harm.Patient condition reported as "fine".
 
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 failed the initial power connect test with a red wrench alarm.The temperature probe set which was attached to the unit was removed and a known good probe set (395-90) was connected.Continuing with the investigation the neptune was again connected to 110 vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.Based on the investigation performed, the reported complaint was confirmed.The root cause is associated with a faulty temperature probe which was returned with the neptune.The concha smart neptune displayed no functional issues.
 
Event Description
Customer complaint alleges the control panel of the device is not displaying fully and therefore cannot access controls for the device settings.Alleged malfunction reported as detected during patient use.It was reported there was no patient injury or harm.Patient condition reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONCHA NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
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 Key6690354
MDR Text Key79179884
Report Number3003898360-2017-00778
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Respiratory Therapist
Type of Report Initial,Followup
Report Date 06/28/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2017
Initial Date FDA Received07/06/2017
Supplement Dates Manufacturer Received08/21/2017
Supplement Dates FDA Received08/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-