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

Catalog Number 382-50

Device Problems Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that the column does not hold compressible volume in the circuit while ventilating in pressure mode.When rt clamps flow tube, the column works to maintain compressible volume, but the water does not flow into the column.The patient's condition is reported as fine.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.The complaint alleged a reported difference over time in volume and/or peak pressure delivered per the reading on the servo i ventilator.Upon clamping of the upper clamp of the column, the values appeared to be go back to original values.The returned conchasmart column was inspected and found to have all components in place and functioning.The sample was subjected to simulated use testing.Tests utilized the same ventilator model as the institution and utilized all settings conveyed by the clinicians.The failure mode could not be recreated.Based on simulated testing, the event could not be duplicated.The root cause is unknown.Teleflex will continue to monitor and trend on occurrences of this type.

Event Description

The customer alleges that the column does not hold compressible volume in the circuit while ventilating in pressure mode.When rt clamps flow tube, the column works to maintain compressible volume, but the water does not flow into the column.The patient's condition is reported as fine.No patient injury or harm reported.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5782060
• MDR Text Key: 49157955
• Report Number: 3004365956-2016-00254
• 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,Followup
• Report Date: 06/16/2016

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: Health Professional
• Device Catalogue Number: 382-50
• Device Lot Number: 74B1600063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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