MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMWEAR FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1133381
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that the dreamwear full face mask with magnetic clips while using with a pacemaker.There was no report of patient harm or injury.The manufacturer has not received the product for investigation.The dreamwear instructions for use includes the following warnings: the headgear clips contain magnets.Contact your healthcare professional before you use this mask.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 in.(50 mm) 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.This report will be filed as an initial-final report.We will continue to monitor these complaints regarding magnets.If any additional information is received, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: DREAMWEAR FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15760073
• Report Number: 2518422-2022-92666
• Device Sequence Number: 8192807
• Product Code: BZD
• UDI-Device Identifier: 00606959046047
• UDI-Public: 00606959046047
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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
• Device Model Number: 1133381
• Device Catalogue Number: 1133381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown