MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; 72",ADULT ANES.CIRCUIT,BI-WYE,ELBOW 2L/LF BAG

Model Number 8264

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Circuit is very rigid preventing proper installation.

Manufacturer Narrative

Reportable as there is a potential of patient injury, should the torque of the circuit cause the ett to move or become dislodged.It could interfere with ventilation.Even though they did report actual harm, there would be a potential for it.

Manufacturer Narrative

Reportable as there is a potential of patient injury- should the torque of the circuit cause the ett to move or becoming dislodge.It could interfere with ventilation.Even though they did report actual harm there would be a potential for it.Could not confirm the complaint due to lack of return or photos from the customer.Reviewed dhr and found no causes for defects.Inspected similar inventory and found no defects.Reviewed complaint history and there were no complaints for this part number in the 24 months preceding the complaint reporting.Root cause cannot be determined, but could be from incorrect storage or transport conditions.Performed risk analysis and determined a severity rating of 7 for the complaint.Sent resolution to the customer.

Event Description

Circuit is very rigid preventing proper installation.

• Brand Name: WESTMED LLC
• Type of Device: 72",ADULT ANES.CIRCUIT,BI-WYE,ELBOW 2L/LF BAG
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tucson AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tucson AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16063024
• MDR Text Key: 307205921
• Report Number: 2028807-2022-00026
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8264
• Device Catalogue Number: 8264
• Device Lot Number: 062722T01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• 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
• Patient Outcome(s): Other