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

Model Number 1133376

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Rash (2033)

Event Date 03/15/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288097356
• Report Number: 2518422-2022-11948
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959046283
• UDI-Public: 00606959046283
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1133376
• Device Catalogue Number: 1133376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male