MAUDE Adverse Event Report: RESMED LIMITED AIR SENSE 10 AUTOSET; VENTILATOR, NON-CONTINUOUS

Model Number 37028

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Fatigue (1849); Scar Tissue (2060); Discomfort (2330); No Code Available (3191)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Defects recalls reported on medical equipment by two international government agencies.Air seepage from upper nose cushion around eyes.Neck trapezius stiffness binding associated with headgear, neck gear.Some congestion documented, some dry mouth documented associated with regular equipment usage.Slight to low bruises.Scar tissue around upper facial cheek regions.Difficulty meeting physician's seven hour per night usage requirement.General discomfort.Some fatigue, some drowsiness associated with usage.Batch # 1264794, device # 031.

• Brand Name: AIR SENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): RESMED LIMITED; 1 elizabeth macarthur drive; bella vista 2153 ; AS 2153
• MDR Report Key: 7453695
• MDR Text Key: 106567760
• Report Number: MW5076653
• 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: 04/12/2018

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: 37028
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 89