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

Catalog Number 425-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt the unit was visually inspected for outward, visible signs of misuse/abuse/neglect (physical check, tp-1).No significant issues were noted in terms of physical damage.No significant amount of lint built up on fan or cooling ports.Functional investigation the neptune was conducted.The unit passed the initial power connect test (tp-3).The unit also navigated through the power-on self-test (p.O.S.T.) (tp-4) with no issues.The next test was the temperature display accuracy test (tp-5) using the diagnostic probe kit, part number 425-99, and the following simulated values.The neptune displayed the correct temperatures and properly alarmed in the high temperature scenario.The device history record investigation did not show issues related to the complaint.The complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.No corrective/preventative actions will be assigned.

Event Description

The customer alleges that the power flickered on and off while on a patient.The patient's condition is reported as fine and no harm reported.

• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5906212
• MDR Text Key: 53095168
• Report Number: 3003898360-2016-00825
• 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,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• 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: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2008
• 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