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

Model Number	1133376
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging patient developed a rash from using a dream wear full face mask.The patient required prescription steroid cream to address the issue.The patient is continuing to use the mask and the device will not be returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported medical device problem code: 3190 (insufficient information).After review, the medical device problem code should be 4001 (patient device interaction problem).The manufacturer previously reported required intervention to prevent permanent impairment/damage in section b2.After review, it was determined that required intervention to prevent permanent impairment/damage was incorrectly selected and other serious or important medical events should have been selected.The user was prescrbed a steroid cream to alleviate a rash.There was no allegation of serious or permanent harm or injury.

• Brand Name: DREAM WEAR FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13937440
• Report Number: 2518422-2022-11948
• Device Sequence Number: 3889045
• Product Code: BZD
• UDI-Device Identifier: 00606959046283
• UDI-Public: 00606959046283
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 12/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male