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

Model Number 63406

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 07/31/2023

Event Type  Death  

Event Description

The facts of the event are currently unknown.It was reported to resmed that a patient went to a hospital in respiratory distress.At some point and it is not clear when, the patient used an airfit f20 mask with a stellar 150 device.It is not clear if this use was before or at the hospital.The cause of the patient¿s respiratory distress is unknown.The patient stabilized and transferred to the observation station in the emergency room where the patient expired.It was reported the soft cushion of an airfit f20 mask had allegedly separated from its rigid part.It is unknown how the airfit f20 mask was fitted to the patient.It is also unknown whether the alleged separation caused any injury to the patient.There was no allegation of malfunction of the stellar device.

Manufacturer Narrative

The airfit f20 mask is not available to be returned to resmed for evaluation.The investigation methods, results and conclusion are not finalized at this stage.If more information becomes available, a supplemental report will be submitted.The aiffit f20 user guide states," 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 states: "the airfit f20 is: to be used by patients weighing more than 66 lb.(30 kg) for whom positive airway pressure therapy has been prescribed.Intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment." airfit f20 user guide provides the following instructions for re-assembly of the mask, "attach the cushion to the frame by aligning the circular openings and pushing together until retained." the stellar 150 user guide states that ¿the stellar 150 is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar 150 is not a life support ventilator¿.The stellar user guide also provides the following indications for use: - ¿the stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (13kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea.¿ resmed reference#: (b)(4).

Event Description

The facts of the event are unknown to resmed.It was reported to resmed that the patient, who was on non invasive therapy while at home, went to a hospital in respiratory distress.The cause of the patient¿s respiratory distress is unknown.The patient was stabilized in the emergency room and transferred to an observation station in the emergency room where the patient expired some time later.In the emergency room, patient was placed on an airfit f20 mask provided by the hospital.It is unknown how the airfit f20 mask was fitted to the patient.The soft cushion of the airfit f20 mask allegedly separated from its rigid part.It is unknown whether the separation caused or contributed to any injury to the patient.There is information that the patient may have received therapy via a resmed stellar 150 device.While in the emergency room.It is not known if the stellar device came to the hospital from the patient's home or was provided by the hospital.There is no allegation of any malfunction of the stellar device.

Manufacturer Narrative

The airfit f20 mask was discarded by the hospital.Visible separation of the silicone membrane and chassis of the cushion was confirmed through a photo provided to resmed.Based on all available evidence, an initial investigation determined the root cause of the reported complaint is unable to be determined.When further information becomes available, a follow-up report will be submitted.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRFIT F20 MED SYS - EU1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17967651
• MDR Text Key: 326076975
• Report Number: 3004604967-2023-00582
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63406
• Device Catalogue Number: 63406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/27/2024
• Date Manufacturer Received: 03/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male