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

Catalog Number 425-00

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product usage when the alleged issue was detected is unknown.The device was received by the manufacturer for evaluation, but the results of the investigation are incomplete at the time of this report.The device history record investigation did not show issues related to complaint.

Event Description

The customer alleges that the unit will not recognize the probe.

Manufacturer Narrative

Qn#(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.When the power on button is released the unit immediately drops out with no response.This failure is indicative of a defective power supply pcb.The on-board power supply pcb was by-passed with a known good power supply pcb and the test was attempted again, this time successfully.Based on the investigation performed, the reported complaint was confirmed.It was determined that the power supply pcb is defective.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 18 apr 2007 and will be replaced.

Event Description

The customer alleges that the unit will not recognize the probe.

• 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 Key: 5675533
• MDR Text Key: 45762508
• Report Number: 3003898360-2016-00544
• 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,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• 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: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2007
• 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