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

Model Number 1110411

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/15/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an end user was hospitalized several times due to arrythmia, paroxysmal atrial fibrillation, chronic heart failure, and increases in pulse after wearing the wisp mask with magnetic connections.It was reported, that in one instance, the user's pulse increased when he had the mask on, and then returned to normal 30 minutes after removing the mask.The user reportedly has a magnet-implanted defibrillator, so the doctor replaced the mask with another model.No product will be 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.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Event Description

Upon visual inspection of the actual product by philips japan, it was confirmed that there were no scratches, deformation, or breakage that would affect the usage of the mask.The manufacturer has requested the return of the mask for further investigation.If additional information becomes available to the manufacturer at a later date, an addendum to this report will be filed.

Manufacturer Narrative

The manufacturer previously reported information alleging an end user was hospitalized several times due to arrhythmia, paroxysmal atrial fibrillation, chronic heart failure, and increases in pulse after wearing the wisp mask with magnetic connections.It was reported, that in one instance, the user's pulse increased when he had the mask on, and then returned to normal 30 minutes after removing the mask.The user reportedly has a magnet-implanted defibrillator, so the doctor replaced the mask with another model.After review, it was determined the manufacturer omitted the visual inspection from the previously reported mdr.The manufacturer should have also stated: upon visual inspection of the actual product by philips japan, it was confirmed that there were no scratches, deformation, or breakage that would affect the usage of the mask.The manufacturer has requested the return of the mask for further investigation.

• Brand Name: WISP MASK
• Type of Device: 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: 15713430
• MDR Text Key: 302825713
• Report Number: 2518422-2022-90075
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 1110411
• Device Catalogue Number: 1110411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male