MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMWEAR FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1133400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An end user alleged the magnets in a dreamwear full face mask affected his medtronic automatic implantable cardioverter defibrillator (aicd) when the mask strap popped off, resulting in the mask coming in close contact with and resetting the aicd.There was no report of serious or permanent injury, and no medical intervention was required.The end user discontinued use of the dreamwear mask , was given a different mask to use by his provider, and has had no further incidents.The mask was not returned to the manufacturer.Labeling included with the mask warns the user "the headgear clips and mask cushion contain magnets.Contact your healthcare provider before you use this mask.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 inches away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators, and cochlear implants.The manufacturer will continue to monitor complaints for trends.No further action is necessary at this time.
Additional Manufacturer Narrative
The manufacturer previously reported this event as an adverse event and product problem.A second review indicates this is a product problem only.There was no serious or permanent injury, and no medical intervention was required.

• Brand Name: DREAMWEAR FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14498622
• Report Number: 2518422-2022-18133
• Device Sequence Number: 5579290
• Product Code: BZD
• UDI-Device Identifier: 00606959045897
• UDI-Public: 00606959045897
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1133400
• Device Catalogue Number: 1133400
• Device Lot Number: 190320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male