MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMWEAR GEL PILLOWS MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1135048
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the silicone part of the mask melted and a runny nose.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Correction to the previously reported information: the manufacturer received information alleging the mask melted and caused a runny nose on a dreamwear gel pillows mask.Medical intervention was not specified.The dreamwear gel pillows mask was returned to a service center for evaluation, and the applicable part was inspected and confirmed that the gel portion of the gel pillow cushion at one side has been torn then the gel had flown out.Since the flew gel adhered to the surroundings, the broken portion was hard to be identified.Confirmed that there was no abnormality in the gel cushion another side.The applicable part was sent to the manufacturer for further investigation.The product is not listed under the scope of recall.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In this report, box b, d, h has been updated/corrected.

• Brand Name: DREAMWEAR GEL PILLOWS 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17455667
• Report Number: 2518422-2023-18246
• Device Sequence Number: 7152958
• Product Code: BZD
• UDI-Device Identifier: 00606959048485
• UDI-Public: (01)00606959048485
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 1135048
• Device Catalogue Number: 1135048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/23/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Male