CONCHATHERM NEPTUNE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-14 for CONCHATHERM NEPTUNE * manufactured by Teleflex Inc.

Event Text Entries

[19659026] Upper middle part of the high flow circuit melted and stuck to bed linen. The humidifier did not alarm; temperature reading 28 degrees celsius; circuit felt hot to the touch (felt hotter than 37 degrees c). Condensation noted below the melted part of circuit; very little condensation noted above it. Detached high flow circuit from the nsala cannula and unplugged power plug of neptune humidifier. Administered 02 blow by via bag and mask; patient sat saturation recovered. The melted circuit had been in use for approximately 7 days.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1999606
• MDR Report Key: 1999606
• Date Received: 2011-02-14
• Date of Report: 2011-02-14
• Date of Event: 2011-01-30
• Report Date: 2011-02-14
• Date Reported to FDA: 2011-02-14
• Date Added to Maude: 2011-02-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CONCHATHERM NEPTUNE
• Generic Name: HEATED HUMIDIFIER
• Product Code: BTT
• Date Received: 2011-02-14
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX INC
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Device Sequence Number: 2

• Brand Name: HEATED WIRE CIRCUIT
• Generic Name: HEATED WIRE CIRCUIT
• Product Code: OFP
• Date Received: 2011-02-14
• Model Number: *
• Catalog Number: 780-20
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TELEFLEX INC HUDSON RCI
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Device Sequence Number: 3

• Brand Name: CONCHA COLUMN
• Generic Name: CONCHA COLUMN
• Product Code: BTT
• Date Received: 2011-02-14
• Model Number: *
• Catalog Number: 385-30
• Lot Number: *
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: TELEFLEX INC HUDSON RCI
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-02-14