MAUDE Adverse Event Report: SALTER LABS SALTER LABS; AIRQ3 SELF PRESSURIZING ILA WITH AUTOMATIC CUFF INFLATION AND GA,

Model Number 60305, 60405

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

These parts were part of a product notification and customer field action.In addition, incidents occurred during the use of establishing or maintaining airways.The criteria for reporting an adverse event have been met based on the reported information.

Event Description

Max gastric tube sizing not able to be placed down the air q3.

Manufacturer Narrative

These parts were part of a product notification and customer field action.In addition, incidents occurred during the use of establishing or maintaining airways.The criteria for reporting an adverse event have been met based on the reported information.Complaint confirmed.Sizing discrepancy is the root cause and was documented in ncmr-02867.Risk analysis performed with rma-20024b determined a severity rating of 6.Sent resolution to the customer with ncmr information.

Event Description

Max gastric tube sizing not able to be placed down the air q3.

• Brand Name: SALTER LABS
• Type of Device: AIRQ3 SELF PRESSURIZING ILA WITH AUTOMATIC CUFF INFLATION AND GA,
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16386794
• MDR Text Key: 309893477
• Report Number: 3000219639-2023-00004
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/16/2023

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: 60305, 60405
• Device Catalogue Number: 60305, 60405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 03/30/2023
• 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