MAUDE Adverse Event Report: RESMED CORP. RESMED F20 CPAP HEADGEAR; VENTILATOR, NON CONTINUOUS RESPIRATOR

Model Number F20

Device Problems Product Quality Problem (1506); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Event Description

My third failure of resmed cpap f20 headgear in a short period of time (failure in 117, 65, and 54 days of use).I have used the resmed f20 headgear for two years since (b)(6) 2017 until (b)(6) 2019 without any problems.The small magnets (that look like button batteries, which are a danger to children swallowing them) tear through their vinyl plastic holding cover and fall out.This prevents the headgear strap from connecting to the face frame unit and makes headgear unusable.(b)(6) insurance only covers replacement every 90 days or the local supplier charges for a replacement.The simple solution for the customer is to replace the inexpensive plastic magnet holder as it threads through the velcro attached headgear.I contacted resmed, and requested an inexpensive replacement of the plastic magnet holder or a replacement headgear but they refused to replace either option directly with the customer.They suggest i work through my local supplier ((b)(4)).(b)(4) refused to work with me in returning the defective headgear to resmed and refused to provide any support or free replacement for third failure.The only thing they wanted to do was sell me at high cost a replacement resmed headgear.If you don't notice the attaching magnet coming out and falling on the floor until you go to use it the next night, it is a danger to small children picking it up and swallowing it.Fda safety report id # (b)(4).

• Brand Name: RESMED F20 CPAP HEADGEAR
• Type of Device: VENTILATOR, NON CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 8722726
• MDR Text Key: 149084902
• Report Number: MW5087511
• Device Sequence Number: 3
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F20
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 91