MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMWEAR FULL FACE MASK

Model Number	1133376
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of an allegation from a user of the dreamwear full face mask with magnetic headgear was possibly causing his sound bridge implant to malfunction.The user is worried that the issue with the implant could be due to the magnets.The user also stated that the sound bridge is four inches away from the magnets.There was no patient harm or injury reported.No mask or headgear will be returning for investigation.The patient is getting a new mask with no magnets.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.
Additional Manufacturer Narrative
No product returned for investigation.

• Brand Name: DREAMWEAR FULL FACE MASK
• Common Device Name: FULL FACE MASK
• 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: 15986351
• Report Number: 2518422-2022-101929
• Device Sequence Number: 17573820
• Product Code: BZD
• UDI-Device Identifier: 00606959046283
• UDI-Public: 00606959046283
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1133376
• Device Catalogue Number: 1133376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES90705
• Patient Sequence Number: 1
• Patient Sex: Male