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

Model Number	1094051
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation that a user after wearing a wisp mask with magnetic connections, the user reportedly had a seizure.The user has a history of seizures and has an implanted shunt and vns for his seizures.The following day it was also reported the user suffered 7 additional seizures.The mother of the user reported she is not sure if the seizures were related to the magnets in the mask or not.There was no report of medical intervention.Several attempts were made to contact the user's mother for the return of the mask for investigation.No product was returned 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: 13666049
• Report Number: 2518422-2022-07486
• Device Sequence Number: 4995801
• Product Code: BZD
• UDI-Device Identifier: 00606959006829
• UDI-Public: 00606959006829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,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
• Device Lot Number: 180322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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 INFORMATION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male