MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT N30I SML CUSHION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 63813

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 02/05/2023

Event Type  malfunction  

Event Description

Airfit n30i sml cushion ref (b)(4), lot (10)1632134; product has a molding defect (short shot) so the connector to the mask is not fully formed.Product would not connect to mask.No injury, product could not be used.See scanned pages.

• Brand Name: AIRFIT N30I SML CUSHION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD
• MDR Report Key: 16336823
• MDR Text Key: 309306523
• Report Number: MW5114800
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 63813
• Device Lot Number: (10)1632134
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Female