MAUDE Adverse Event Report: RESMED LTD ACUCARE HFNC - MEDIUM (20PK)

Model Number 23004

Device Problem Split (2537)

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

Event Type  malfunction  

Manufacturer Narrative

The device is currently being returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.Resmed reference #: (b)(4).The device is currently being returned to resmed.

Event Description

It was reported to resmed that a hospital patient had an oxygen desaturation due to a cushion tear in the nasal cannula tubing of an acucare mask.There was no patient injury reported as a result of this incident.

Manufacturer Narrative

The acucare hfnc nasal cannula was not returned to resmed for an extensive engineering investigation.No product was returned and no lot number or pictures were not provided for investigation, therefore, the report that the cannula tore at the nasal connection cannot be confirmed.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported torn tubing was most likely due to the overall membrane thickness of the cannula.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed that a hospital patient had an oxygen desaturation due to a cushion tear in the nasal cannula tubing of an acucare mask.There was no patient injury reported as a result of this incident.

• Brand Name: ACUCARE HFNC - MEDIUM (20PK)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: david duley ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 5948246
• MDR Text Key: 54889825
• Report Number: 3004604967-2016-01026
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 23004
• Device Catalogue Number: 23004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/19/2017
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1