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

Model Number	1094051
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Cognitive Changes (2551)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation from a user that while using the wisp mask with magnetic clips with his cpap device, he reported that he experienced headaches right after he started using it.The user reports he wore the mask with magnets a few years before he realized that the headaches and cognitive issues from the headaches were from the magnets in his mask.The user reported several cat scans and a visit to the hospital for the shunt in his head to be adjusted.The user reported he stopped using his mask when his cpap machine broke (b)(6) 2019.The user no longer has the wisp mask with the magnetic clips.No product will be returning for investigation.The wisp instructions for use includes the following warnings: the headgear clips contain magnets.Contact your healthcare professional 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 in.(50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.Do not use in or near magnetic resonance imaging (mri) equipment.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.This report will be filed as an initial-final report.We will continue to monitor these complaints regarding magnets.If any additional information is received, a follow up report will be filed.

• Brand Name: WISP 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: 13666050
• Report Number: 2518422-2022-07487
• Device Sequence Number: 4995802
• Product Code: BZD
• UDI-Device Identifier: 00606959006829
• UDI-Public: 00606959006829
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K 121631
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 1094051
• Device Catalogue Number: 1094051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PAP DEVICE- NO SN PROVIDED
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male