MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC WISP NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Vomiting (2144); Eye Pain (4467)

Event Date 11/29/2022

Event Type  Injury  

Event Description

The manufacture received a voluntary medwatch (mw5113452), alleging a user of a wisp nasal mask with magnetic headgear, had pain in the left eye while using the mask.The user has a history of double vision and a brain aneurysm behind the left eye.In 2009, an aneurysm bypass surgery with coiling procedure was performed.The user now alleges dry eye and eye drops were prescribed.The user alleges the pain in eye has gotten worse, with vomiting and staying in bed all day.Over the past three years, the user has had multiple doctor visits, neurologists, including an ent doctor and pulmonary specialist to seek help.A neurologist, specializing in aneurysm coiling, stated his findings conclude a likelihood of a change in or around the coiling.Upon receiving the recall letter from philips, the user immediately ceased the use of the wisp nasal mask with the magnets.User states he alleges that the wisp nasal mask is a contributing factor to his diminishing quality of health.No product returning for investigation.This will be an initial-final report.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

No product was returned for investigation.

Manufacturer Narrative

The manufacture previously reported information after receiving a voluntary medwatch (mw5113452), alleging a user of a wisp nasal mask with magnetic headgear, had pain in the left eye while using the mask.The user has a history of double vision and a brain aneurysm behind the left eye.In 2009, an aneurysm bypass surgery with coiling procedure was performed.The user now alleges dry eye and eye drops were prescribed.The user alleges the pain in eye has gotten worse, with vomiting and staying in bed all day.Over the past three years, the user has had multiple doctor visits, neurologists, including an ent doctor and pulmonary specialist to seek help.A neurologist, specializing in aneurysm coiling, stated his findings conclude a likelihood of a change in or around the coiling.Upon receiving the recall letter from philips, the user immediately ceased the use of the wisp nasal mask with the magnets.User states he alleges that the wisp nasal mask is a contributing factor to his diminishing quality of health.No product returning for investigation.This will be an initial-final report.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

• Brand Name: WISP NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16013703
• MDR Text Key: 306109886
• Report Number: 2518422-2022-102508
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES90705
• Patient Sequence Number: 1
• Patient Outcome(s): Other