MAUDE Adverse Event Report: RESMED CORP AIRMINI TRAVEL CPAP; VENTRICULAR, NON CONTINUOUS (RESPIRATOR)

Model Number 600

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Dyspnea (1816)

Event Date 10/12/2018

Event Type  Injury  

Event Description

I am a cpap patient and purchased a resmed airmini from apria direct in (b)(6) 2018.A prescription was provided to the company to have the cpap setting at 6.0 and the machine was received at the factory preset setting of 4.0.I am presently "experience" extreme breathing difficulties in using this product.I have contacted the company on several occasions and there has been no resolution of the problem.

• Brand Name: AIRMINI TRAVEL CPAP
• Type of Device: VENTRICULAR, NON CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 8176317
• MDR Text Key: 131226465
• Report Number: MW5082254
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2018

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: Lay User/Patient
• Device Model Number: 600
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 96