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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Atrial Fibrillation (1729)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

The face mask instructions for use include the following warnings: the mask assembly contains magnets.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 6 inches (approx.15.24 cm) 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.Device not returned to manufacturer.

Event Description

The manufacturer received information from an end user's wife alleging her husband has a pacemaker and had afib in the summer while using the wisp mask with magnets.The user's wife was wondering when it was known the magnets caused issues.There was no report of medical intervention.The user's wife has a call into the doctor regarding this.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• 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 15208 ; 4125423300
• MDR Report Key: 17030896
• MDR Text Key: 316241941
• Report Number: 2518422-2023-12486
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 90705
• Patient Sequence Number: 1
• Patient Outcome(s): Other