MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID VENT FILTER,SMALL,ANGLED,CLEAN; CONDENSER, HEAT AND MOISTURE

Catalog Number 18502

Device Problem Pressure Problem (3012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

It was reported that "problems encountered with circuit: circuit too compliant - expands with each tidal volume.High paco2 noted, because fraction of tidal volume lost in circuit.Necessitates higher minute volume (frequency) to compensate.Especially problematic in high airway pressure.Circuit moves with each tidal volume.".

• Brand Name: HUDSON HUMID VENT FILTER,SMALL,ANGLED,CLEAN
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5764871
• MDR Text Key: 48637961
• Report Number: 8040412-2016-00129
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2016

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: 18502
• Device Lot Number: PR020039896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1