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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a wisp mask with magnets interfered with a user's dental implants.The end user has been using the mask since last year and noticed 2 to 3 months ago the implants in her mouth have moved.The user was scheduled to see the dentist on (b)(6) 2022.The user contacted her provider and is using a different mask.Multiple attempts to contact the user for additional information have been unsuccessful.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer previously became aware of an allegation that a wisp mask with magnets interfered with a user's dental implants.The end user has been using the mask since last year and noticed 2 to 3 months ago the implants in her mouth have moved.The user was scheduled to see the dentist on november 3, 2022.The user contacted her provider and is using a different mask.Multiple attempts to contact the user for additional information have been unsuccessful.No product will be returned for investigation.The manufacturer previously reported this event as both an adverse event and product problem.After review, it is determined this allegation should have been a product problem only as there is insufficient evidence to pronounce a serious injury.

• 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: 15815542
• MDR Text Key: 303828178
• Report Number: 2518422-2022-94474
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 10/27/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 02/08/2024
• 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): Other
• Patient Age: 68 YR