MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; RESPIRATORY GAS HUMIDIFIER

Catalog Number 395-90

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

(b)(4).The investigation into this complaint is still on going at the time of this report.

Event Description

Customer complaint alleges that during use, when attempting to access the controls, the change temperature gradient would not display.The therapist replaced the heater unit(event captured in mfr rpt# 3003898360-2017-00778) and still the control panel was not available.Alleged malfunction reported as detected during use.It was reported there was no patient harm.

Manufacturer Narrative

(b)(4).A limited root cause investigation was performed due to the condition of the returned part.The temperature probe was returned destroyed and missing the sensing element.The customer stated that the original issue was thought to be to the equipment and not this probe.It was also reported by the customer that they clipped the ends off the probe.A dhr review was also performed and concluded that there were no abnormalities found related to manufacturing or components.

Event Description

Customer complaint alleges that during use, when attempting to access the controls, the change temperature gradient would not display.The therapist replaced the heater unit(event captured in mfr rpt# 3003898360-2017-00778) and still the control panel was not available.Alleged malfunction reported as detected during use.It was reported there was no patient harm.

• Brand Name: HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A
• 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: 6757620
• MDR Text Key: 81514249
• Report Number: 3003898360-2017-00839
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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 Number: 395-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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