MAUDE Adverse Event Report: RESMED LTD ACTIVOX P4L US STD PKG

Model Number AOX-P4L-US

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed's preliminary risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an activox 4l device had a low oxygen purity error message and the patient went to the hospital as a result of having breathing difficulties.

Manufacturer Narrative

The activox device was returned to resmed for an investigation.Performance testing confirmed that the device was not producing oxygen within specification.The investigation determined that the root cause was degraded material.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 an activox 4l device had a low oxygen purity error message and the patient went to the hospital as a result of having breathing difficulties.

• Brand Name: ACTIVOX P4L US STD PKG
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 7306796
• MDR Text Key: 101407213
• Report Number: 3004604967-2018-00374
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113317
• 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,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AOX-P4L-US
• Device Catalogue Number: AOX-P4L-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/30/2018
• Device Age: 6 MO
• Date Manufacturer Received: 04/30/2018
• 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
• Patient Weight: 109