MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 MED SYS QUIET-EU1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 64006

Device Problem Break (1069)

Patient Problem Cardiac Arrest (1762)

Event Date 10/19/2022

Event Type  Death  

Manufacturer Narrative

The broken clip was returned to resmed for evaluation.The rest of the airfit f20 mask was not returned.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.The airfit f20 user guide provides the following warning: - ¿if any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.¿ the airfit f20 user guide also provides the following statement: - ¿the f20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (pap) device such as a continuous positive airway pressure (cpap) or bilevel system.¿ resmed reference#: pr 2851667 h3 other text : pending investigation.

Event Description

It was reported to resmed that a patient receiving ventilation from a non-resmed device and using a resmed airfit f20 mask expired.It was reported that the magnetic clip of the mask broke during use.The patient was alone at the time of the reported incident and the patient was unable to reconnect the mask or obtain a replacement mask.The customer reported the coroner determined the patient died due to motor neuron disease and also due, in some part, to a failure in the ventilation equipment, the broken clip on the mask.

Manufacturer Narrative

The magnetic clip of the airfit f20 mask system was returned to resmed for an investigation.Based on all available evidence and complaint investigations of a similar nature, it was determined that the reported complaint was due to a combination of sub optimum corner radius and possible external contamination of the magnetic clip.Cracks and fractures were found on the magnetic area of the clip where no mechanical stress is applied through the headgear.It is not possible to determine if the mask clip was broken due to a design or manufacturing defect, normal wear and tear, or physical abuse.A design change has since been implemented as an outcome of a previous investigation.It appears that the patient, who was a ventilator-dependent patient, was left unattended and without supervision on site.In the dependent population, it is an expected clinical practice that the patient would be monitored and cared for continuously by a carer, to be able to take appropriate action if anything unwanted were to occur, and also, an alternative means of ventilation would be readily available.These expectations were not met in this case.The airfit f20 user guide provides the following warning: ¿if any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.¿ the user guide also provides the following statement: ¿the f20 is a non invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (pap) device such as a continuous positive airway pressure (cpap) or bilevel system.¿ resmed's risk analysis for this failure mode concludes that the risk is determined to be unchanged from the original accepted risk level and, therefore, is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient receiving ventilation from a non-resmed device and using a resmed airfit f20 mask expired.It was reported that the magnetic clip of the mask broke during use.The patient was alone at the time of the reported incident and the patient was unable to reconnect the mask or obtain a replacement mask.The customer reported the coroner determined the patient died due to motor neuron disease and also due, in some part, to a failure in the ventilation equipment, the broken clip on the mask.

• Brand Name: AIRFIT F20 MED SYS QUIET-EU1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17604905
• MDR Text Key: 321763385
• Report Number: 3007573469-2023-00484
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 64006
• Device Catalogue Number: 64006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2023
• Distributor Facility Aware Date: 08/24/2023
• Event Location: Home
• Date Report to Manufacturer: 09/23/2023
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Female