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

Catalog Number 382-10

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "low water notification didn;t go away, so they squeezed the bottle to get water in the column.They ended up changing the column and the column was dry." no patient harm reported.The condition of the patient is listed as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was performed and the sample failed the pressure decay testing, and the column function test.The device history record of batch number 74e1900832 was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the functional inspection of the sample received, the complaint is confirmed.A non-conformance has been created in order to address the root cause and action plan for the reported issue.In addition, personnel of the assembly line will be notified for awareness.

Event Description

The complaint is reported as: "low water notification didn;t go away, so they squeezed the bottle to get water in the column.They ended up changing the column and the column was dry." no patient harm reported.The condition of the patient is listed as "fine".

• Brand Name: UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8915617
• MDR Text Key: 155063747
• Report Number: 3004365956-2019-00218
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: 382-10
• Device Lot Number: 74E1900832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2019
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED