MAUDE Adverse Event Report: RESMED LTD AIRTOUCH F20 MED - AMER

Model Number 63001

Device Problem Compatibility Problem (2960)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device to be returned so an engineering investigation could be performed.The device has not been returned for investigation at this time.Based on information provided, the type and location of the cerebrospinal fluid (csf) shunt used in the patient are not known to resmed.The airtouch f20 user guide provides the following warning: ¿magnets are used in the lower headgear straps and the frame of the airtouch f20.Ensure the headgear and frame is kept at least 2 inches (50 mm) away from any active medical implant (e.G.Pacemaker or defibrillator) to avoid possible effects from localized magnetic fields.The magnetic field strength is less than 400 mt." resmed is unable to confirm the reported complaint of headgear magnetic clips interfering with the csf diversion device.(b)(4).

Event Description

It was reported to resmed that the magnets on an airfit f20 mask interfered with a cerebrospinal fluid (csf) diversion device or shunt.It was reported the patient was hospitalized and is now recovered.

Event Description

It was reported to resmed that the magnets on an airfit f20 mask interfered with a cerebrospinal fluid (csf) diversion device or shunt.It was reported the patient was hospitalized and is now recovered.

Manufacturer Narrative

The airfit f20 mask was not returned to resmed.An investigation was performed on all available information.The investigation determined that there was no fault found.There is no evidence suggesting that the alleged incident was due to device malfunction.The airtouch f20 user guide provides the following warning: - ¿magnets are used in the lower headgear straps and the frame of the airtouch f20.Ensure the headgear and frame is kept at least 2 inches (50 mm) away from any active medical implant (e.G.Pacemaker or defibrillator) to avoid possible effects from localized magnetic fields.The magnetic field strength is less than 400 mt." resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRTOUCH F20 MED - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9325083
• MDR Text Key: 166519753
• Report Number: 3004604967-2019-00365
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K153563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63001
• Device Catalogue Number: 63001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2020
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 05/03/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1