MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; RESPIRATORY GAS HUMIDIFIER

Catalog Number 425-00

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection: the device showed no signs of misuse/abuse/neglect.No significant amount of lint built up on fan or cooling ports.The unit was gently rotated and then lightly shaken, nothing loose noted.Functional inspection: the device passed the initial power connect test, and the power-on self-test with no issues.The neptune displayed the correct temperatures and properly alarmed in the high temperature scenario.Functional testing did not reveal any operational anomalies.A device history record investigation did not show issues related to complaint.A record assessment (fmea) was conducted and no changes required.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.

Event Description

Customer complaint alleges "display flashing on and off".Alleged defect detected prior to use.No report of patient involvement.

• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6165835
• MDR Text Key: 62238762
• Report Number: 3003898360-2016-01101
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1