MAUDE Adverse Event Report: RESPIRONICS, INC. S, DREAMWEAR UTN, SM FRM W/ HGR, GBL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1116685
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
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 to have a rash and bumps on the back of her head no other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Mdr 2518422-2024-43374 was submitted in error, this is not a reportable event.This is a non uno event.The manufacturer received information alleging to have a rash and bumps on the back of her head.No other clinical information or medical interventions were reported.Based on the available information, there is not enough evidence to indicate this issue is reportable to any regulatory agencies.If upon evaluation of the device a reportable issue/malfunction is identified, this decision will be re-evaluated using the date of the repair evaluation as the "become aware" date if a reportable issue/malfunction.

• Brand Name: S, DREAMWEAR UTN, SM FRM W/ HGR, GBL
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19707854
• Report Number: 2518422-2024-43374
• Device Sequence Number: 6851672
• Product Code: BZD
• UDI-Device Identifier: 00606959030787
• UDI-Public: 00606959030787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/06/2024

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: 1116685
• Device Catalogue Number: 1116685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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: Z-1974-2021
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female