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  Injury  

Manufacturer Narrative

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

Event Description

It was reported to resmed that a hospital patient had an oxygen desaturation due to a tear in the corrugated tubing of an acucare mask.The mask was delivering oxygen to the patient at the time their desaturation was observed.The tear in the mask tubing resulted in no harm to the patient.

Manufacturer Narrative

The acucare hfnc nasal cannula was returned to resmed for an extensive engineering investigation.Visual inspection confirmed the report that the acucare nasal cannula was torn.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 in older product design.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 tear in the corrugated tubing of an acucare mask.The mask was delivering oxygen to the patient at the time their desaturation was observed.The tear in the mask tubing resulted in no harm to the patient.

• 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 CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 5992431
• MDR Text Key: 56101372
• Report Number: 3004604967-2016-01073
• Device Sequence Number: 1
• Product Code: BYG
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23004
• Device Catalogue Number: 23004
• Device Lot Number: R1769765A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/17/2017
• Date Manufacturer Received: 09/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1