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

Model Number	1137944
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that the dreamwisp mask with magnetic clips allegedly caused itching to the side of their nose and air comes out into her face.There was no report of medical intervention.There was no report of serious patient harm or injury.No product will be returned for investigation.The dreamwisp mask is intended to provide an interface for application of continuous positive airway pressure (cpap) or bilevel therapy to patients.The mask is intended for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66 lbs/30kg) for whom cpap or bi-level therapy has been prescribed.The dreamwisp mask 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.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

• Brand Name: DREAMWISP 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: 15759371
• Report Number: 2518422-2022-92671
• Device Sequence Number: 15511195
• Product Code: BZD
• UDI-Device Identifier: 00606959051126
• UDI-Public: 00606959051126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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
• Operator of Device: Lay User/Patient
• Device Model Number: 1137944
• Device Catalogue Number: 1137944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• 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: Female