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

Model Number IPN041365

Device Problems Incorrect Measurement (1383); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported as "the failure is that the filter port is non-functional because it did not allow to provide accurate capnography results".It was reported that the "filters were well conditioned and allowed good ventilation of the children.However, they did not in any way provide a possibility of monitoring fio2 and capnography".The water trap and capnography lines were changed as soon as the problem appeared.The malfunction was confirmed by the biomedical engineer.Further information states "there was no significant impact for the child, but it is difficult to perform blind anesthesia without reliable monitoring".

Manufacturer Narrative

Qn#(b)(6) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported as "the failure is that the filter port is non-functional because it did not allow to provide accurate capnography results".It was reported that the "filters were well conditioned and allowed good ventilation of the children.However, they did not in any way provide a possibility of monitoring fio2 and capnography".The water trap and capnography lines were changed as soon as the problem appeared.The malfunction was confirmed by the biomedical engineer.Further information states "there was no significant impact for the child, but it is difficult to perform blind anesthesia without reliable monitoring".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16966579
• MDR Text Key: 315650425
• Report Number: 8040412-2023-00210
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/02/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: IPN041365
• Device Catalogue Number: 11012T
• Device Lot Number: KMZ22M0339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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