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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Implant Pain (4561)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that an end user has metal bars behind the top and bottom of their front teeth and the teeth started shifting 2.5 years ago while using a philips magnetic mask.The user alleges she had the metal bars placed to keep teeth aligned after having braces 30 years ago.The user alleges her teeth are out of line, crooked, she cannot floss in between them, and she has headaches.The user states she purchased a new mouth guard which is helping, but she is still in pain.There was no report of serious patient harm or injury.There was no report of medical intervention.Attempts to obtain more information about which philip's mask the patient was using were unsuccessful.No product will be returned for investigation.The user stopped using the mask on 12/17/2022.The manufacturer suggested using another mask without magnetic clips.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.The user is warned, "consult a physician or dentist if you encounter tooth, gum, or jaw soreness.Use of a mask may aggravate an existing dental condition." the 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.Not returned to manufacturer.

• 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: 16121495
• MDR Text Key: 307097129
• Report Number: 2518422-2023-01046
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2022
• 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: RES90705
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female