MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM

Catalog Number 425-00

Device Problems Device Stops Intermittently (1599); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

The customer alleges that the device spontaneously shuts down and restarts will on the pt.No pt injury and no jeopardy to the pt from the incident, per the user facility.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per dhr (device history record) the product concha neptune, serial # (b)(4) was manufactured on 11/21/2012.The dhr investigation did not show issues related to complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time since the device sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determinate the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate bc 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn regulatory aff ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4317164
• MDR Text Key: 5129020
• Report Number: 3003898360-2014-00910
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• 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: Unknown
• Patient Sequence Number: 1