MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; COMFORT SOFT PLUS, INFANT NASAL CANNULA, HIGH FLOW LT BLUE

Model Number	0558
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interruption of flow could lead to hypoxia.
Event or Problem Description
Occlusion.
Additional Manufacturer Narrative
Interruption of flow could lead to hypoxia.Complaint history reviewed.There have been no other complaints for 0558 cannula.Trend data shows downward trend in cpm for product group 84-o2 cannula westmed.Without lot# or rm, further investigation cannot take place.Most likely root cause of occlusion is too much bonding agent applied when product was assembled, or one of the tubing was inserted too far into the facepiece.Assembly is a manual process and even with quality controls in place occasionally defects may occur and not be caught.Risk(rma-20017f): r22: oxygen delivery interrupted - cannula oxygen tubing occlusion - s=8 o=2 rpn=16.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
Occlusion.

• Brand Name: WESTMED LLC
• Common Device Name: COMFORT SOFT PLUS, INFANT NASAL CANNULA, HIGH FLOW LT BLUE
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17175391
• Report Number: 2028807-2023-00018
• Device Sequence Number: 3534540
• Product Code: CAT
• UDI-Device Identifier: 00709078001871
• UDI-Public: 00709078001871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0558
• Device Catalogue Number: 0558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown