MAUDE Adverse Event Report: RESMED LTD AIRCURVE 10 S USA TRI

Model Number 37214

Device Problem Device Stops Intermittently (1599)

Patient Problems Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for evaluation.A review of the downloaded device logs showed high occurrences of air leaks.Inspection revealed physical damage to the device and tape was placed over the filter door.The internal components were contaminated by dust and an unknown substance causing the device to not function properly.Based on the evaluation results, the device failure was due to physical damage and internal contamination.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient was hospitalized due to an oxygen desaturation when the aircurve cpap shut down.

• Brand Name: AIRCURVE 10 S USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6091506
• MDR Text Key: 59869140
• Report Number: 3004604967-2016-01210
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37214
• Device Catalogue Number: 37214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/11/2016
• Device Age: 21 MO
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1