MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; CIRCUIT, DISPOSIBLE, ADULT MRI, 96",

Model Number 9317

Device Problem Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

The distal end of the coaxial circuit had an obstruction in the internal (inspiratory) limb and when the outer limb was cut open, the internal limb was found to be twisted and greater than 75% occluded.This impacted the patient's pro-longing induction to anesthesia.Based on the reported information the criteria for reporting an adverse event have been met.

Event Description

Unable to deliver set tidal volume to the patient.

Manufacturer Narrative

The distal end of the coaxial circuit had an obstruction in the internal (inspiratory) limb and when the outer limb was cut open, the internal limb was found to be twisted and greater than 75% occluded.This impacted the patient's pro-longing induction to anesthesia.Based on the reported information the criteria for reporting an adverse event have been met.Summary: product not returned and complaint could not be confirmed.Review of complaint history shows similar complaints for leaks through a split tube.Customer notified of complaint history and actions taken to correct the non-conformance.Ra: rma-20017c reviewed for patient not getting intended oxygen level - r36 identifies applicable risk.

Event Description

Unable to deliver set tidal volume to the patient.

• Brand Name: WESTMED LLC
• Type of Device: CIRCUIT, DISPOSIBLE, ADULT MRI, 96",
• 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: 16163419
• MDR Text Key: 308484090
• Report Number: 2028807-2023-00001
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9317
• Device Catalogue Number: 9317
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• 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