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

Model Number 1094051

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

The instructions for use will 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.Mask and headgear still in use, not returning.

Event Description

The manufacturer became aware of an allegation that a user's dental implant fell out while using a wisp mask with magnets.The user states about two years ago her dental implant fell out and she saw a specialist to have the tooth removed.There was no serious patient harm or injury reported.No product is returning for investigation.The user was advised to remove the magnets in her mask and to order the plastic clips for the replacement.This is 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

Corrected data includes: type of reported complaint being changed to product problem.

Manufacturer Narrative

On previously submitted report, box b: "adverse event or product problem" was incorrect.In this report, box b: "adverse event or product problem" has been updated/corrected.

• Brand Name: WISP 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: 16131263
• MDR Text Key: 307196297
• Report Number: 2518422-2023-01176
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1094051
• Device Catalogue Number: 1094051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2023
• 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: A
• Removal/Correction Number: RES90705¿¿¿¿¿¿
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Female