MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE

Model Number IPN041363

Device Problem Gas Output Problem (1266)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that "when the filter was attached during the anesthetic, we were unable to get any co2 trace.We opened a new box w ith a different batch number and this rectified the issue".The customer confirmed that "the three filters were changed for the one patient.The third filter was a different batch and was able to provide a trace." no patient harm or injury.The patient status is reported as "fine".See associated mdr #8040412-2023-00327.

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "when the filter was attached during the anesthetic, we were unable to get any co2 trace.We opened a new box w ith a different batch number and this rectified the issue".The customer confirmed that "the three filters were changed for the one patient.The third filter was a different batch and was able to provide a trace." no patient harm or injury.The patient status is reported as "fine".See associated mdr #8040412-2023-00327.

• Brand Name: HUMID VENT PEDI
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17595129
• MDR Text Key: 321635878
• Report Number: 8040412-2023-00328
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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 Model Number: IPN041363
• Device Catalogue Number: 11011T
• Device Lot Number: KMH23A0089
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2023
• 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
• Treatment: N/A.; N/A.